MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSE GLENOID BASPLT INSRTR SCREWDRVR T20; SCREWDRIVER

Catalog Number	MWJ123
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that both ends of the screwdrivers chipped off during use.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Additional Manufacturer Narrative
The reported event was confirmed since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following the visual inspection of the returned device exhibits extensive usage evident by the significant scratches and gouge marks on the screwdriver shaft and handle.The distal end or at the tip of the device of the device broken.The shiny and planar breakage patterns are indicative of brittle fracture.The fragmented part of the device was not available for inspection.Furthermore, a hardness test according to rockwell on the returned item indicates the material being slightly above in accordance with the values in the material specification.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation the root cause was attributed to a combination of wear and user related issue.The failure was caused by repetitive usage and exposure to extensive torsional load contributing to the event.If any further information is provided the complaint report will be updated.
Event or Problem Description
It was reported that both ends of the screwdrivers chipped off during use.

• Brand Name: TORNIER PERFORM REVERSE GLENOID BASPLT INSRTR SCREWDRVR T20
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20398055
• Report Number: 0001649390-2024-00577
• Device Sequence Number: 6518037
• Product Code: HXX
• UDI-Device Identifier: 00846832062461
• UDI-Public: 00846832062461
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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: Lay User/Patient
• Device Catalogue Number: MWJ123
• Device Lot Number: AZ6222215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown