MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER SHAFT T25/SHORT/6MM HXC; SCREWDRIVERS

Model Number 03.620.022

Device Problem Break (1069)

Patient Problems Nerve Damage (1979); Pain (1994); No Code Available (3191)

Event Date 06/06/2017

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(64).The reported event required medical/surgical intervention to preclude permanent damage to a body structure.The screwdriver broke intraoperatively, the broken pieces punctured the patient's internal organs causing palsy injuries including nerve injuries to her arms, legs, and back, disability and pain.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: the investigation could not be completed; no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on or about (b)(6) 2017, the patient underwent an unknown procedure using a t25 stardrive screwdriver shaft to install a screw in the patient's back.During this procedure, the screwdriver fractured and punctured the patient's internal organs and bodily structures.As a result, the patient suffered palsy injuries including nerve injuries to her arms, legs, and back, disability and pain.Concomitant devices reported: unknown screw (part# unknown, lot# unknown, quantity# unknown).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Manufacturing location: supplier- (b)(4).Manufacturing date: april 07, 2006 part: 03.620.022, stardrive screwdrivr shaft t25/short/6mm hxc lot: 5143771 (non-sterile) lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming / final inspection met all inspection acceptance criteria.Certificate of compliance received from universal punch was reviewed and determined to be conforming.Hardness was certified.Packaging label log was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture or inspection that would contribute to this complaint condition.Visual inspection: the instrument was not returned and instead the investigation will be done based on the supplied image(s).The image was reviewed and the complaint condition for broken could not be confirmed as the image does not show the distal tip of the instrument.As the instrument(s) was not returned, an as received, dimensional, material, or drawing reviews are not applicable.The photo identifies part number and lot number of the device, but does not show the section of device which was alleged to be broken.There are no clear signs of damage in the photo provided, and therefore, the complaint condition can not be confirmed.Investigation conclusion: this complaint was not able to be confirmed or replicated, and no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on or about (b)(6) 2017, the patient underwent a procedure to treat a degenerative lumbar disc disease, l5-s1, l4-5, herniated disc l5-s1 and l4-5, post-laminectomy syndrome, l5-s1, chronic back pain and bilateral lumbar radiculopathy acquired from a previous laminectomy procedure.A t25 stardrive screwdriver shaft was used to install a screw in the patient's back.During this procedure, the screwdriver broke, resulting in a laceration of the left iliac vein and subsequent thrombosis of the left iliac artery.At the end of the procedure, the patient was stable but as a result of the laceration, suffered palsy injuries including nerve injuries to the arms, legs, and back, disability, and pain.Concomitant devices: screw (part: unknown, lot: unknown, quantity: unknown).This report is for a stardrive screwdriver shaft.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h6: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device history (lot) manufacturing location: supplier- universal punch / monument manufacturing date: apr 07, 2006 part number: 03.620.022, stardrive screwdriver shaft t25/short/6mm hxc lot number: 5143771 (non-sterile) lot quantity: 210 work order traveler met all inspection acceptance criteria.Inspection sheet, incoming / final inspection, 03ii620022 rev a met all inspection acceptance criteria.Certificate of compliance received from universal punch for op # 10 (vendor machine/heat treat) dated apr 03, 2006 was reviewed and determined to be conforming.Hardness specified at hrc 56-60 was certified as 58.2.Packaging label log lppf, lmd/lpf was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture or inspection that would contribute to this complaint condition.26-sep-2019: dhr reviewed device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: updated data: h6.Investigation summary visual inspection: the instrument was not returned and instead the investigation will be done based on the supplied image(s) from the attachments (1 image from the attachment located in notes & attachments section of the product complaint).The image was reviewed and the complaint condition for broken could not be confirmed as the image provided does not show the distal tip of the instrument.As the instrument(s) was not returned an as received, dimensional, material or drawing reviews are not applicable.The photo identifies part number and lot number of the device, but does not show the section of device which was alleged to be broken.There are no clear signs of damage in the photo provided, and therefore, the complaint condition can not be confirmed.Device failure/ defect identified? no complaint confirmed? no.Investigation conclusion: this complaint was not able to be confirmed or replicated and no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Photo investigation the device was not returned.A photo-investigation was performed on the x-ray images and photographic images.Review of all other file attachments dated through 01mar2021 was also completed.The x-ray images depicted a piece of material assumed to be the tip of the reported broken screw driver remaining in a screw.The photograph of the screwdriver only depicted the devices part and lot, and the tip was not visible.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion the complaint was confirmed.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.As indicated in the surgeon's dictation of the event, they reported to have appropriately tightened the screws to "torque tightness", then performed a subsequent step of "over-tightening", leading to the broken screwdriver tip.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: device history lot - manufacturing location: supplier- universal punch / monument manufacturing date: 07-apr-2006.Part number: 03.620.022, stardrive screwdrivr shaft t25/short/6mm hxc.Lot number: 5143771 (non-sterile) lot quantity: 210.Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming / final inspection, 03ii620022 rev a met all inspection acceptance criteria.Certificate of compliance received from universal punch for op # 10 (vendor machine/heat treat) dated 03-apr-2006 was reviewed and determined to be conforming.Hardness specified at hrc 56-60 was certified as 58.2.Packaging label log lppf, lmd/lpf rev a was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture or inspection that would contribute to this complaint condition.,manufacturing location: supplier- universal punch / monument manufacturing date: 07-apr-2006 part number: 03.620.022, stardrive screwdrivr shaft t25/short/6mm hxc lot number: 5143771 (non-sterile) lot quantity: 210 work order traveler met all inspection acceptance criteria.Inspection sheet, incoming / final inspection, 03ii620022 rev a met all inspection acceptance criteria.Certificate of compliance received from universal punch for op # 10 (vendor machine/heat treat) dated 03-apr-2006 was reviewed and determined to be conforming.Hardness specified at hrc 56-60 was certified as 58.2.Packaging label log lppf, lmd/lpf rev a was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture or inspection that would contribute to this complaint condition.Device history review =- 26-sep-2019: dhr reviewed by: (b)(6) this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.,(b)(6) 2019: dhr reviewed by: mschoenfeld this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On (b)(6), 2017, the patient underwent anterior lumbar discectomy and interbody fusion (alif) at the l5-s1 level done at good samaritan hospital.In the surgery the left l5 screw was proud and did not seat with the 7nm torque limiting screwdriver.While tightening the left l5 screw the screwdriver shaft broke at the junction of star slots and the main screwdriver shaft.The screwdriver shaft broke obliquely and the screwdriver was then inadvertently advanced into the left iliac vein resulting in a laceration.The tip of the screwdriver with the star slots was stuck in the screw head and was unable to dislodge.The broken screwdriver tip was left in the screw head as the patient had a life threatening vascular injury which took precedence.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: b6.Tests/lab data including dates.B7.Medical history/preexisting condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported the patient had an additional revision surgery due to this event on (b)(6), 2019.This event is captured on related complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: h3, h6: an additional photo investigation was completed: additional documents were received and reviewed.The review of the x-ray images and medical records does not change the findings of the previous investigation.The root cause was traced to user error, and no corrective and/or preventive action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: STARDRIVE SCREWDRIVER SHAFT T25/SHORT/6MM HXC
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8876350
• MDR Text Key: 153801054
• Report Number: 2939274-2019-59610
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10705034717616
• UDI-Public: (01)10705034717616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.620.022
• Device Catalogue Number: 03.620.022
• Device Lot Number: 5143771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 08/08/2019
• Supplement Dates Manufacturer Received: 09/26/2019; 03/26/2021; 03/30/2021; 06/28/2021; 07/20/2021; 01/21/2022; 05/06/2022; 06/29/2022
• Supplement Dates FDA Received: 10/15/2019; 03/27/2021; 03/31/2021; 06/28/2021; 07/29/2021; 01/21/2022; 06/03/2022; 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA.
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female