MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.5MM #2 MB 10PK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE/SPORTS MEDICINE

Catalog Number	912015
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: china.H3: 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 while the surgeon was inserting the implant into the patient, the tip of the device fractured and was retained in the patient.There is no information that the surgeon plans to attempt to revise the patient to remove the foreign body from the patient.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.Visual examination of the provided photo identified the prong of the inserter tip has fractured.However, as the product has not returned, further analysis could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: JGRKNT 1.5MM #2 MB 10PK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE/SPORTS MEDICINE
• 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: 23066921
• Report Number: 0001825034-2025-02928
• Device Sequence Number: 15915058
• Product Code: MBI
• UDI-Device Identifier: 00880304516557
• UDI-Public: (01)00880304516557(17)290103(10)0002579281
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110145
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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: 912015
• Device Lot Number: 0002579281
• Was Device Available for Evaluation?: No
• 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: 10/20/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Unknown