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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a primary closure of the sternum following an isolated avr, the titanium band attached to the 4 hole box plate, implanted towards the xyphoid process, fractured while the surgeon was approximating the sternal halves by pulling up on the titanium band.As a consequence, the band could not be used to approximate the sternal halves towards the xyphoid process.The preceding multi-implant plates and band were implanted without issue.For the affected plate/band, the surgeon elected to remove the broken titanium band and locking mechanism.He then elected to implant the second 4-hole box plate anteriorly without issue.The closure continued without incident and the patient was not affected by the fractured titanium band.There was no patient injury as a result of the malfunction.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4) g2: foreign: australia 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The previously reported lot number was determined to be incorrect by inventory transaction history.Therefore, this has been updated to unknown.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned product.The device was returned without packaging and no lot number was present.The inspection shows signs of use including marking on the device surface.The tensioner shows that it has been partially tightened, the inspection also showed that the tensioner band has fractured.Roughly half of the band remains in the tensioner while the remaining portion of the fractured band was returned as well.Medical records were not provided.Review of the device history record(s) 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.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to update additional information in sections b4, b5, d4, d9, g3, g6, h2, h6 and h10.

• Brand Name: SL360 MULTI-IMPLANT SYSTEM
• Common Device Name: PLATE, FIXATION, 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: 17070228
• Report Number: 0001032347-2023-00216
• Device Sequence Number: 5885819
• Product Code: HRS
• UDI-Device Identifier: 00888233026604
• UDI-Public: (01)00888233026604(17)280130(10)250050
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/10/2023

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 Model Number: N/A
• Device Catalogue Number: 74-0004
• Device Lot Number: 250050
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 08/31/2023; 10/12/2023; 11/06/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 09/27/2023; 10/20/2023; 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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
• 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
• Patient Sex: Male