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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "surgeon was installing a glenosphere onto the baseplate with the screwdriver.The surgeon noticed the white handle of the tool started spinning without turning the shaft of the driver.The smaller, ratcheting torx bit had to be used to finish installing the glenosphere.Realized after the case the metal rod broke off in the white handle.".
Event or Problem Description
As reported: "surgeon was installing a glenosphere onto the baseplate with the screwdriver.The surgeon noticed the white handle of the tool started spinning without turning the shaft of the driver.The smaller, ratcheting torx bit had to be used to finish installing the glenosphere.Realized after the case the metal rod broke off in the white handle.".
Additional Manufacturer Narrative
Please note the correction to d4 gtin.The reported event could be confirmed since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following.The received device shows significant signs of extensive usage as evident by heavy circular marks and scratches on the shaft and black spots on the handle.The shaft of the screwdriver is broken from the handle.There is also a clear presence of dark red brown spots or undetermined residue on the shaft even after going through decontamination.Moreover a hardness test was performed on the cylindrical surface closest to the fractured surface of the returned item.The avg.Value indicates the material being over the limit with the accordance range.This can be explained by the small diameter of the device as well as the rounded surface.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 user and wear related issue.The failure was caused by an application of excessive mechanical force and improper usage.If any further information is provided the complaint report will be updated.

• 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: 20925068
• Report Number: 0001649390-2024-00710
• Device Sequence Number: 5055865
• Product Code: HXX
• UDI-Device Identifier: 00846832062461
• UDI-Public: (01)00846832062461(11)200120(10)AZ2519241
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/04/2025

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: Health Professional
• Device Catalogue Number: MWJ123
• Device Lot Number: AZ2519241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2020
• 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