MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING DEVICE FOR GUIDE WIRES AND REAMING RODS; SCREWDRIVER

Model Number	03.010.024
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative 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 or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the surgeon was attempting to advance the 2.5 mm reaming rod down the femoral canal with the holding device for the reaming rod.When the surgeon flipped the switch on the handle to lock once the trigger was depressed, an attempt was made to advance the reaming rod holding device, but it would still slide down the reaming rod.The procedure was completed successfully with a five (5) minute delay.Concomitant devices: unknown holding device (part# unknown, lot# unknown, quantity 1).This report is for one (1) holding device for guide wires and reaming rods.This is report 1 of 1 for (b)(4).
Additional 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: h6 - codes updated to imdrf codes.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the images attached in the notes & attachments section of pc titled "alfn rod gripper_august 13th, 2021.Jpg" and "alfn overview handle reaming rod gripper_august 13th, 2021.Jpg".The images were reviewed, and the complaint condition is not confirmed.As the device was not returned, it cannot be verified that it cannot grip a rod.There are no visual defects that could potentially lead to the complaint condition.A definitive assignable root cause could not be determined based on the provided information.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.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - part number: 03.010.024 lot number: t156500 manufacturing site: tuttlingen release to warehouse date: 19-mar-2018 a review of the device history records was performed for the finished device lot number, and no non-conformances were identified.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.
Additional 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 or Problem Description
Concomitant device : (product code: 60.031.001, lot number: fl00197, quantity: 1).
Additional 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.D9.Date device returned to manufacturer.H4.Device manufacture date.H6 - codes updated to imdrf codes.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the images attached in the notes & attachments section of pc titled "alfn rod gripper_august 13th, 2021.Jpg" and "alfn overview handle reaming rod gripper_august 13th, 2021.Jpg".The images were reviewed, and the complaint condition is not confirmed.As the device was not returned, it cannot be verified that it cannot grip a rod.There are no visual defects that could potentially lead to the complaint condition.A definitive assignable root cause could not be determined based on the provided information.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.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Background: surgeon was attempting to advance the 2.5 mm reaming rod down femoral canal with the holding device for reaming rod.Surgeon flipped the switch on handle to lock once trigger was depressed but when attempt was made to advance the reaming rod holding device would still slide down reaming rod.Visual inspection: the hand f/guide wire+reaming rod (p/n: 03.010.024, lot number: t156500) was received at juarez pal.Visual examination of the returned device did not find any indication of a product defect.Functional test a functional test to lock the device was conducted.It was observed that the device would not lock when the trigger is pulled after flipping the locking switch.However, if the trigger is pulled before flipping the locking switch, the device will lock successfully.The investigation was able to replicate the complaint condition.A functional test for holding the reaming rod was not performed as the mating device was returned.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage.Complaint relevant dimensions cannot be taken.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: the functional test was able to replicate the reported event.The device failed to lock which contributed to the complaint condition.Of unable to assemble.The overall complaint was confirmed for the received device.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.Device history lot - part number: 03.010.024 lot number: t156500 manufacturing site: tuttlingen release to warehouse date: 19-mar-2018 a review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Part# 03.010.024 synthes lot# t156500 supplier lot# t156500 release to warehouse date: 26july2018 supplier: (b)(4) no ncrs were generated during production.Device history review -review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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.

• Brand Name: HOLDING DEVICE FOR GUIDE WIRES AND REAMING RODS
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12457293
• Report Number: 2939274-2021-05296
• Device Sequence Number: 11610876
• Product Code: HXX
• UDI-Device Identifier: 10886982067005
• UDI-Public: (01)10886982067005
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.010.024
• Device Catalogue Number: 03.010.024
• Device Lot Number: T156500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 09/28/2021; 11/02/2021; 02/09/2022
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 10/25/2021; 11/02/2021; 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - GRASPING/HOLDING INSTRUMENTS
• Patient Sex: Unknown