MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER NEXEL TOTAL ELBOW TORQUE DRIVER; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Catalog Number	00840108000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - the event occurred in japan.The customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that after the operation was performed, during postoperative x-ray imaging, the doctor discovered a piece of metal near the humeral component.The shape of the piece closely resembled the tip of a screwdriver.Upon inspection of the screwdriver, it was found that the tip was fractured.There are currently no plans to perform surgery to remove the broken piece.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6.The reported event is confirmed through returned product evaluation.Visual examination of the returned product identified the elbow torque driver returned shows signs of use.The end of the driver has fractured off of the device and the fractured piece was not returned with 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.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a metal piece projecting immediately lateral to the humeral component at the level of the axle pin may possibly represent a broken tip of the screwdriver.Per the device surgical technique, the user is instructed to "tighten the screws to the prescribed torque." under proper use, the driver should experience torsional forces.As analysis of the returned device identified the fracture is due to bending overload, the root cause of the reported issue is attributed to use error.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: ZIMMER NEXEL TOTAL ELBOW TORQUE DRIVER
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22922911
• Report Number: 0001822565-2025-03189
• Device Sequence Number: 10223186
• Product Code: JDC
• UDI-Device Identifier: 00889024272200
• UDI-Public: (01)00889024272200(17)290212(10)56708043
• 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): 02/03/2026

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: Lay User/Patient
• Device Catalogue Number: 00840108000
• Device Lot Number: 56708043
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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