MAUDE Adverse Event Report: TORNIER S.A.S. D. 3MM DRILL BIT-LG 220MM-STRYKER/ZIMMER-HALL QUICK CONNECT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	MWB107
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
While drilling for the baseplate screws, the drill bit broke within the patient's scapula.The drill was too far in the extract so surgeon placed shorter screw in the same hole.The drill still in patient.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation.The device inspection was not possible as the product was not returned for investigation.However, based on provided scans, medical expert opinion was asked and the scans confirm that the drill bit is in the subscapularis muscle belly, not embedded in the scapular bone.The shorter screw may stabilize the baseplate if the bio-rsa bone graft fully incorporates.While it is standard for surgeons to drill through the glenoid vault, occasional overshooting into soft tissues can occur, and drill breakage may result from encountering hard materials or excessive flexing.Additionally, an offset drilling angle could contribute to breakage, though without further details, the exact cause remains uncertain.The 3d ct scan further verifies the drill bit near the scapular bone in the right shoulder.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
While drilling for the baseplate screws, the drill bit broke within the patients scapula.The drill was too far in the extract so surgeon placed shorter screw in the same hole.The drill still in patient.

• Brand Name: D. 3MM DRILL BIT-LG 220MM-STRYKER/ZIMMER-HALL QUICK CONNECT
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21912357
• Report Number: 3000931034-2025-00218
• Device Sequence Number: 20661310
• Product Code: HWE
• UDI-Device Identifier: 03700386968709
• UDI-Public: 03700386968709
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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: MWB107
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/09/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Male