MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED HEX SCREWDRIVER F/6.5MM HDLSS COMPRESSION SCR; SCREWDRIVERS

Catalog Number	03.227.041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2019
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.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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, during an orthopedic procedure, a cannulated hexagonal screwdriver's tip broke off upon inserting a 6.5 headless screw in the foot.Broken driver tip came out when guide wire removed.Fragments were generated and removed easily without additional intervention.There was no surgical delay.The procedure was successfully completed with no patient consequence.Concomitant medical products reported: unknown headless screw (part# unknown, lot# unknown, quantity:1); this complaint involves one (1) device.This report is 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.H10 additional narrative: d4: lot number; d8; d11: therapy date; h4.H11 corrected data: g1: physical manufacturer.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.H10 additional narrative: additional data d10 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.H10 additional narrative: visual inspection: the cannulated hexagonal screwdriver f/6.5mm hdlss compression (part # 03.227.041, lot # 8562921, mfg 5-sep-2013) was received with the distal tip of the screwdriver broken off at the point where the screwdriver shaft turns into the distal hexagonal tip.The broken portion of the device was returned.This is consistent with the reported complaint condition, thus confirming the complaint.Conclusion: the complaint condition is confirmed as the cannulated hexagonal screwdriver (part # 03.227.041, lot # 8562921) was received with the distal tip of the screwdriver 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 history lot, part: 03.227.041, lot: 8562921, manufacturing site: bettlach, release to warehouse date: (b)(6) 2013.The broken sub-component 60024082 / screwdriver shaft hcs 6.5 is not lot tracked.Therefore the last three potential work orders that were produced prior to lot 8562921 were reviewed.The review has shown that with stainless steel 1.4123 the correct material was used and that the hardness was within the specification.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: CANNULATED HEX SCREWDRIVER F/6.5MM HDLSS COMPRESSION SCR
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8290566
• Report Number: 2939274-2019-56164
• Device Sequence Number: 14097011
• Product Code: HXX
• UDI-Device Identifier: 10886982077240
• UDI-Public: (01)10886982077240
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup,Followup
• Report Date (Section B): 01/11/2019

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 Catalogue Number: 03.227.041
• Device Lot Number: 8562921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 02/27/2019; 03/06/2019; 02/27/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 03/06/2019; 03/07/2019; 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR