MAUDE Adverse Event Report: BIOMET MICROFIXATION SL360 MULTI-IMPLANT SYSTEM; PLATE, FIXATION

Catalog Number	74-0004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The 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 chest closure, an 8-hole band fractured and was unable to be repaired.Therefore, the surgeon opened another system to complete the procedure.There was no patient injury as a result of the malfunction.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.
Event or Problem Description
It was reported during the chest closure, the 8 hole band fractured and was unable to be repaired.Therefore, the surgeon had to open another system to complete the procedure.This resulted in a slight delay but no injuries to the patient and all pieces of the fracture implant were removed.The correct surgical technique was used.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b5; d4; d9; h1; h2; h3; h4; h6; h11 complaint can be confirmed through the returned product analysis.A visual inspection was conducted on the returned 74-0004 tensioner.The tensioner shows signs of attempted use with very heavy marking on the band.Further inspection of the band shows that it has snapped.There is bending and warping at the location where the band broke.The needle portion of the band was not returned.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: SL360 MULTI-IMPLANT SYSTEM
• Common Device Name: PLATE, FIXATION
• 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: 23511441
• Report Number: 0001032347-2025-00435
• Device Sequence Number: 9705080
• Product Code: HRS
• UDI-Device Identifier: 00888233026604
• UDI-Public: (01)00888233026604(17)300415(10)66924841
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K163007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2026

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: 74-0004
• Device Lot Number: 66924841
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 11/10/2025; 02/23/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/09/2025; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male