MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFIX® EVOLUTION SCREWDRIVER; SCREWDRIVERS

Model Number	03.835.010
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product investigation was conducted.Visual inspection: the synfix evolution screwdriver (p/n: 03.835.010, lot #: l696772) was returned and received at us cq.Upon visual inspection, the distal tip of the screwdriver shaft and the initial distal thread was stripped.There were scratches on the device but has no impact on the functionality of the device.The noted defect is consistent as a potential end of life indicator for the device.No other issues were identified with the returned components of the device.Investigation conclusion: the stripped condition of the driver tip is a potential end of life indicator of the screwdriver.After a visual inspection, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A device history record (dhr) review was conducted: part: 03.835.010, lot: l696772, manufacturing site: (b)(4), release to warehouse date: 18.Jan 2018.A manufacturing record evaluation 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.
Event or Problem Description
It was reported that on an unknown date, during routine incoming inspection of loaner set it was observed that the synfix evolution screwdriver was non functional.There was no patient involvement.During manufacturer's investigation on february 28, 2020 of the returned device it was identified that the distal tip of the screwdriver shaft and the initial distal thread was stripped.This is report 1 of 1 for complaint (b)(4).

• Brand Name: SYNFIX® EVOLUTION 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: 9881161
• Report Number: 2939274-2020-01527
• Device Sequence Number: 19593486
• Product Code: HXX
• UDI-Device Identifier: 10705034814117
• UDI-Public: (01)10705034814117
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 02/12/2020

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: 03.835.010
• Device Catalogue Number: 03.835.010
• Device Lot Number: L696772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1