MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INNER SHAFT FOR EXTRACTION SCREWDRIVER; SCREWDRIVERS

Model Number	03.613.004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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
It was reported that on (b)(6) 2019, the surgeon was performing c3-c7 anterior cervical discectomy and fusion (acdf).While implanting a vectra screw through a vectra plate using the extraction screwdriver, the tip of the inner shaft of the screwdriver broke off into the screw.The tip of the driver fragments was lodged solidly into the implanted screw.Surgeon determined that it was not going anywhere so he determined there was no need to remove the screw (which contained the fragment).He completed the procedure using a different screwdriver.There was no surgical delay or harm to the patient, and there was no loose fragment in the patient.Concomitant devices reported: cervical self-retaining screws, self-drilling (part 04.613.516, lot unknown, quantity 1), titanium vectra plate (part 04.613.132, lot unknown, quantity 1), extraction screwdriver (part 352.311, lot unknown, quantity 1).This report is for an extraction screwdriver.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.A device history record (dhr) review was conducted: part number: 03.613.004, synthes lot number: h212966, supplier lot number: n/a, release to warehouse date: 14jan2017 , expiration date: n/a, supplier: (b)(4).No non-conformance reports (ncrs) were generated during production.The material was reviewed and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.A product investigation was conducted.Visual inspection: the inner shaft for extraction screwdriver (part # 03.613.004, lot # h212966, mfg # 14-jan-2017) was received at us cq with the distal tip broken off.This is consistent with the reported complaint condition, thus confirming the complaint.X-rays were not sent to us cq therefore the embedded condition could not be confirmed.Dimensional inspection: dimensional analysis was completed, the outer diameter the shaft proximal to the fracture site measured and is within specification per relevant drawing.Document/specification review: the relevant drawing(s) was reviewed; the material was reviewed, and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.Conclusion: the complaint condition is confirmed as the inner shaft for extraction screwdriver (part # 03.613.004, lot # h212966) was received with the distal tip broken off.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative 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: INNER SHAFT FOR EXTRACTION SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8426006
• Report Number: 2939274-2019-56990
• Device Sequence Number: 18901431
• Product Code: HXX
• UDI-Device Identifier: 10705034714578
• UDI-Public: (01)10705034714578
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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
• Operator of Device: Health Professional
• Device Model Number: 03.613.004
• Device Catalogue Number: 03.613.004
• Device Lot Number: H212966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR