MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK 360 MULTI-IMPLANT SYSTEM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).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.Medical products: unknown cerclage wire, part# ni, lot# ni, manufacturer unknown.Occupation: distributor on behalf of facility.
Event or Problem Description
It was reported the cable of a sternal closure device fractured while reducing the sternal halves.The device was removed and the patient was closed with wires.No adverse events were reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A4 patient weight ¿ patient was over 400 lbs.
Event or Problem Description
It was reported the cable of a sternal closure device fractured while reducing the sternal halves.The surgeon was trying to tighten the device near the manubrium when the fracture occurred.The device was removed and the patient was closed with multiple wires.The surgeon feels the large anatomy of the patient was responsible for the device failure.No adverse events were reported as a result of the malfunction.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product confirmed that the three assemblies had been used.Each assembly had the metal band fed up through the tensioner and locked in place per step one of the process.The threaded shafts were displaced, indicating the tightening wheels had been rotated to achieve sternal approximation.The metal bands all appeared to have either been fractured or cut.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.The supplier's 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.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: STERNALOCK 360 MULTI-IMPLANT SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10621478
• Report Number: 0001032347-2020-00485
• Device Sequence Number: 11593555
• Product Code: HRS
• UDI-Device Identifier: 00888233026604
• UDI-Public: 00888233026604
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151019
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2021

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 Expiration Date: 10/21/2024
• Device Model Number: N/A
• Device Catalogue Number: 74-0004
• Device Lot Number: 743550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 10/12/2020; 04/08/2021
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 10/16/2020; 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Patient Age: 52 YR