MAUDE Adverse Event Report: TORNIER INC PERFORM REVERSED PHERIPHERAL SCREW DRILL BIT 3.2MM STERILE; BIT, SURGICAL

Catalog Number	MWJ126
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a scheduled left revision reverse total shoulder arthroplasty, the surgeon identified a retained fragment of a drill bit near the poly humeral head liner on intraoperative x-ray imaging.The surgeon subsequently reopened the surgical site to remove the drill bit fragment and replaced the poly humeral head liner.The procedure exceeded the planned surgical time by approximately 90 minutes.The revision was completed successfully, and the patient was transferred to the post-anesthesia recovery unit in stable condition.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
Correction: h6 device code.The reported event was not confirmed since the device was not returned for evaluation and no other evidence was provided for evaluation.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.A review of the labeling did not indicate any abnormalities.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the alleged failure.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that during a scheduled left revision reverse total shoulder arthroplasty, the surgeon identified a retained fragment of a drill bit near the poly humeral head liner on intraoperative x-ray imaging.The surgeon subsequently reopened the surgical site to remove the drill bit fragment and replaced the poly humeral head liner.The procedure exceeded the planned surgical time by approximately 90 minutes.The revision was completed successfully, and the patient was transferred to the post-anesthesia recovery unit in stable condition.

• Brand Name: PERFORM REVERSED PHERIPHERAL SCREW DRILL BIT 3.2MM STERILE
• Common Device Name: BIT, SURGICAL
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23126446
• Report Number: 0001649390-2025-00672
• Device Sequence Number: 7311606
• Product Code: GFG
• UDI-Device Identifier: 00846832062089
• UDI-Public: (01)00846832062089(11)250124(17)300124(10)BA0524024
• 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: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MWJ126
• Device Lot Number: BA0524024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 01/16/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Unknown