MAUDE Adverse Event Report: BIOMET MICROFIXATION STERILE TRAC SYSTEM LONG DOG BONE PL SET; PLATE, BONE

Catalog Number	15-7380
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial procedure, a screw fractured during surgery.All fractured pieces were successfully retrieved.The proper surgical technique was used, and another device was used to complete the procedure.No contributing conditions were reported.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - the event occurred in china.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 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 is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d9, g3, g6, h2, h3, h4, h6, h11.A visual inspection was conducted on the returned 15-7380 set.A total of two screws and the plate were returned.The inspection showed that one of the two screws has fractured at the tip.The fractured tip was not returned.The remaining screw and plate show no damage and are intact.The fractured screw was reviewed with scanning electron microscopy.The fracture surface was heavily smeared but small regions of fracture surface artifacts could be identified.Sheared ductile dimples indicating rotational crack propagation suggests the torsional overload failure mode.Semi-quantitative eds elemental analysis found the material to be consistent with ti-6al-4v titanium alloy (carbon and oxygen deconvoluted from calculation).Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The reported event is confirmed, based on product return.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: STERILE TRAC SYSTEM LONG DOG BONE PL SET
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21735820
• Report Number: 0001032347-2025-00184
• Device Sequence Number: 19845241
• Product Code: JEY
• UDI-Device Identifier: 00888233007078
• UDI-Public: (01)00888233007078(17)290213(10)66037051
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K972322
• 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): 07/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 15-7380
• Device Lot Number: 66037051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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
• Patient Sex: Unknown