MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ELBOW TORQUE DRIVER; PROSTHESIS, ELBOW

Catalog Number	00840108000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during surgery, the tip of the screwdriver fractured when inserting the screw.The surgeon searched for the fragment but was unable to find it, leaving it inside the patient's body.There are currently no plans to perform surgery to remove the broken piece.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Complaint can be confirmed through the returned product analysis.Visual examination of the returned product/provided pictures identified the torque driver is fractured at the distal end of the driver and not all of the pieces were returned.Medical records were not provided.No other damage is noted to the device.Optical images of the device fracture surface exhibit river lines and hinge artifacts suggesting that the device possibly fractured due to bending overload.The device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause has been identified as use error.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ELBOW TORQUE DRIVER
• Common Device Name: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23085200
• Report Number: 0001825034-2025-02944
• Device Sequence Number: 18781462
• Product Code: JDC
• UDI-Device Identifier: 00889024272200
• UDI-Public: (01)00889024272200(17)290321(10)56708044
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 00840108000
• Device Lot Number: 56708044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female