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	Insufficient Information (4580)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
As reported: "in one of my cases today, the tip of the baseplate inserter screwdriver t-20, broke while inserting the baseplate.Before inserting the baseplate, we used the appropriate hard bone drill & 6.5mm central screw tap.The surgeon tried unsuccessfully on multiple occasions and different means to remove the broken tip.She finally burred it down with a highspeed bur.The effort to remove the broken driver tip caused about 10 minutes delay.She was finally about to insert the glenosphere over the baseplate.".
Additional Manufacturer Narrative
Please note the corrections to h6 health impact and h6 results codes.The reported event could be confirmed since the device image available confirm the alleged failure.The device inspection of the available picture of the screwdriver reveals that the tip of the device is broken off.There could be seen spots of water marks as well on the shaft region of the device.The device history record could not be reviewed because the affected device was not returned and the lot number was not communicated.Indications of material manufacturing or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided the investigation report will be reassessed.
Event or Problem Description
As reported: "in one of my cases today, the tip of the baseplate inserter screwdriver t-20, broke while inserting the baseplate.Before inserting the baseplate, we used the appropriate hard bone drill & 6.5mm central screw tap.The surgeon tried unsuccessfully on multiple occasions and different means to remove the broken tip.She finally burred it down with a highspeed bur.The effort to remove the broken driver tip caused about 10 minutes delay.She was finally about to insert the glenosphere over the baseplate.".

• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20995324
• Report Number: 0001649390-2024-00729
• Device Sequence Number: 20913629
• Product Code: HXX
• UDI-Device Identifier: 00846832062461
• UDI-Public: 00846832062461
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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): 04/23/2025

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 64 YR
• Patient Sex: Male