MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM PLATE, 8 HOLE STRAIGHT; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00231.Medical products: sternalock blu system plate, 8 hole straight, part# 73-1952, lot# ni.Mw5099848.
Event or Problem Description
It was reported the patient underwent a revision and replacement of sternal closure plates seven (7) weeks following implantation due to pain and sternal instability.The patient returned to the hospital due to instability and pain and it was found that both plates were fractured.The surgeon removed the fractured plates and re-plated the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
The two (2) plate 8 hole straight (item# 73-1952, lot# unk) were not returned for investigation.Dimensional evaluations could not be performed.Visual examination of the provided photos confirmed the reported plates are fractured in the middle.The two fractured plates don't have any identification etchings, but they both match the print for item# 73-1952.Lot identification is necessary for review of device history records, lot identification was not provided.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.

• Brand Name: STERNALOCK BLU SYSTEM PLATE, 8 HOLE STRAIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11732307
• Report Number: 0001032347-2021-00232
• Device Sequence Number: 3832584
• Product Code: HRS
• UDI-Device Identifier: 00888233000857
• UDI-Public: (01)00888233000857
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K011076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 73-1952
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 09/01/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention