MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCRW 2.4X12MM CANCELOUS LOCKNG; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Fluid Discharge (2686)

Event Date 03/22/2023

Event Type  malfunction  

Event Description

It is reported that the patient underwent a procedure and subsequently post operative drainage was observed from the drain attached to the patient.The following day, a computed tomography scan of the treatment site showed that the plate that had been attached to the sternum, had fallen off.Also, the screws had fallen into the chest cavity.In the sternal body and talar body, all screws on the one side had fallen out and were in the chest cavity.The patient remains under observation and no further intervention is currently planned.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Concomitant medical products: item# 73-2643, lot# j7354048, sternalock blu plate 4 hole l 100 deg, qty 1.Item# 73-2623, lot# j7397832, sternalock blu plate 8 hole x, qty 2.Item# 73-2412, lot# unk, sternalock® blu system scrw 2.4x12mm cancelous lockng, qty 11.Report source foreign: japan.The device will not 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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2023-00183 0001032347-2023-00184, 0001032347-2023-00185, 0001032347-2023-00197, 0001032347-2023-00196, 0001032347-2023-00195, 0001032347-2023-00194, 0001032347-2023-00192, 0001032347-2023-00191, 0001032347-2023-00190, 001032347-2023-00189, 0001032347-2023-00188;,0001032347-2023-00187, 0001032347-2023-00186.

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.Lot identification is necessary for review of device history records, lot identification was not provided for the screws.A definitive root cause cannot be determined.The reported event cannot be confirmed.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 Description

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

• Brand Name: STERNALOCK BLU SYSTEM SCRW 2.4X12MM CANCELOUS LOCKNG
• Type of Device: 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: 16945916
• MDR Text Key: 315540046
• Report Number: 0001032347-2023-00193
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 73-2412
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10