MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 14MM; PLATE, FIXATION, BONE

Model Number N/A

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

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Date 12/08/2021

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial cardiac surgery on an unknown date and the patient's sternum was closed with wire.Sometime afterward, on an unknown date, the patient presented with transverse sternal fractures as well as a 2.5cm gap in his sternum that did not heal.The patient then underwent a second procedure where the surgeon removed the wire and replaced it with sternal plating.Afterward, on an unknown date, part of the two plates used became dislodged from the sternum.All of the screws were intact in and still locked in the plate.Subsequently, the patient underwent a revision surgery in which the surgeon removed all sternal hardware and replaced it with new sternal plating.The surgeon believes that the gap in the sternum and the transverse fractures contributed to the instability of the chest and was not related to the use of the sternal plating.He did not think the further non-union of the sternum was due to the original usage of the plating.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Concomitant medical products: zimmer biomet 8 hole sternal plate catalog#: 73-1952 lot#: unknown.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: 0001032347-2022-00005, 0001032347-2022-00006, 0001032347-2022-00007, 0001032347-2022-00008, 0001032347-2022-00009, 0001032347-2022-00010, 0001032347-2022-00011.

Event Description

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

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.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.Patient comorbidities of previous transverse sternal fractures along with reported 2.5cm gap may have contributed to the instability of the chest.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 BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 14MM
• 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: merrianne cassidy ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13175757
• MDR Text Key: 283310038
• Report Number: 0001032347-2022-00004
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110574
• 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: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 73-2414
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male