MAUDE Adverse Event Report: TORNIER INC CORTILOC/PEGGED QUICK RELEASE DRILL BIT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY

Catalog Number	MWH685
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the glenoid preparation for the augmented (cortiloc +) implant, the anti-rotation peg drill broke into two pieces.One piece came out, and one piece remained in the patient.Approximately 45 minutes was spent trying to remove the remaining piece from the patient.X-ray imaging and arthroscopy were used to try to remove the piece but were unsuccessful.The surgeon decided to proceed with surgery, leaving one piece of the anti-rotation peg drill in the patient.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
Correction to device code, clinical signs code and health impact codes., the reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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
It was reported that during the glenoid preparation for the augmented (cortiloc +) implant, the anti-rotation peg drill broke into two pieces.One piece came out, and one piece remained in the patient.Approximately 45 minutes was spent trying to remove the remaining piece from the patient.X-ray imaging and arthroscopy were used to try to remove the piece but were unsuccessful.The surgeon decided to proceed with surgery, leaving one piece of the anti-rotation peg drill in the patient.

• Brand Name: CORTILOC/PEGGED QUICK RELEASE DRILL BIT
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY
• 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: 23840503
• Report Number: 0001649390-2025-00959
• Device Sequence Number: 21193580
• Product Code: HWE
• UDI-Device Identifier: 00846832071074
• UDI-Public: 00846832071074
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/18/2026

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: MWH685
• Device Lot Number: N/A
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/18/2026
• 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: Other; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Unknown