MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 18MM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Foreign source: germany.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.
Event or Problem Description
It was reported that during a procedure that one screw from a 4-pack was inserted with a cordless screwdriver as the 31st of a total of 32 screws.The screw fractured off before it could be fully countersunk into the sternum.The screw head fractured leaving the threaded part in the patient's sternum.The other three (3) screws of this 4-pack were previously used with the patient with no issues.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned screw.The screw shows signs of attempted using including marking on the screw head and shaft.The screw shaft has fractured.The complaint is confirmed.A determination cannot be made as to what caused the screw to fracture.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.This report is being submitted to update additional information in section b4, b5, d4, g3, g6, h2, h3, h4, h6 and h10.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 18MM
• 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: 15379271
• Report Number: 0001032347-2022-00286
• Device Sequence Number: 5820607
• Product Code: HRS
• UDI-Device Identifier: 00888233000918
• UDI-Public: (01)00888233000918(17)260915(10)185493
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K110574
• 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
• Report Date (Section B): 02/10/2023

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 Expiration Date: 09/15/2026
• Device Model Number: N/A
• Device Catalogue Number: 73-2418ST-4PK
• Device Lot Number: 185493
• 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: 08/26/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown