MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5MM HEX SCREWDRIVER SHAFT; MISC ORTHO SURGICAL INSTR

Model Number	03.037.029
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is company employee.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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
It was reported on (b)(6) 2020, during inspection process, the tip of the hexagonal screwdriver shaft was noted to be broken and unusable.There was no patient involvement.This is report 1 of 1 for complaint (b)(4).
Additional 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.H3, h4, h6: a review of the device history record.Part: 03.037.029; lot: 9535733; manufacturing site: hägendorf; release to warehouse date: 18 sep 2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: investigation summary background: it was reported that on (b)(6) 2020, the tip of the hexagonal screwdriver shaft broke off and unusable.It is unknown if there was a patient involvement.This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the 5 mm hex screwdriver shaft (p/n: 03.037.029, lot #: 9535733) was returned and received at us cq.Upon visual inspection, it was observed that the distal tip of the device was broken and the broken fragment was not returned.There were scratches on the device but has no impact on the functionality of the device.No other issues were identified with the returned device.Dimensional inspection was performed on the returned device.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed : screwdriver shaft hex5 w/qc hex6: se-427149, rev.B/c.The device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint condition is confirmed for the 5 mm hex screwdriver shaft (p/n: 03.037.029, lot #: 9535733).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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 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: 5MM HEX SCREWDRIVER SHAFT
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9728232
• Report Number: 2939274-2020-00912
• Device Sequence Number: 19358042
• Product Code: LXH
• UDI-Device Identifier: 10886982070456
• UDI-Public: (01)10886982070456
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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: 03.037.029
• Device Catalogue Number: 03.037.029
• Device Lot Number: 9535733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1