MAUDE Adverse Event Report: BIOMET MICROFIXATION SL360 MULTI-IMPLANT SYSTEM; STERNAL FIXATION DEVICE

Catalog Number 74-0004

Device Problems Fracture (1260); Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4) it is currently unknown whether the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that during a sternal fixation procedure, the lock would not engage to hold tension and the band broke.Another sternalock kit was used to complete the procedure.No patient injury or delay was involved.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.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.

Event Description

No further event information available at the time of this report.

• Brand Name: SL360 MULTI-IMPLANT SYSTEM
• Type of Device: STERNAL FIXATION DEVICE
• 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: 17585147
• MDR Text Key: 321741796
• Report Number: 0001032347-2023-00336
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888233026604
• UDI-Public: (01)00888233026604(17)280221(10)65910368
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 74-0004
• Device Lot Number: 65910368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1