MAUDE Adverse Event Report: SYNTHES GMBH 3.5 HEX SCRDRIVER SFT/SELF-RETAINING; SCREWDRIVER

Model Number	324.050
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection: the 3.5 hex scrdriver sft/self-retaining (p/n: 324.050, lot number: 9059162) was received at us cq.Visual inspection of the complaint device showed the distal tip was bent and twisted.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: se_210500 rev c (current) and rev a( manufactured) were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the distal tip was bent and twisted.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.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 - a manufacturing record evaluation was performed for the finished article lot 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, the tip of power shaft screwdriver was bent and no longer usable.This report is for one (1) 3.5 hex scrdriver sft/self-retaining.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 3.5 HEX SCRDRIVER SFT/SELF-RETAINING
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12428626
• Report Number: 8030965-2021-07504
• Device Sequence Number: 19778044
• Product Code: HXX
• UDI-Device Identifier: 10886982191052
• UDI-Public: (01)10886982191052
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2021

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: 324.050
• Device Catalogue Number: 324.050
• Device Lot Number: 9059162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 09/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1