MAUDE Adverse Event Report: BIOMET MICROFIXATION THE LOW PROFILE STERNAL CLOSURE SYSTEM T15 HEXALOBE DRIVE; DRIVER, PROSTHESIS

Model Number	201.047.15
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).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 cabg procedure, a torque limiter was not placed on the drill and the tip of the screw blade broke off and was later discovered to be left in the patient.The procedure was completed as planned and it was not noted until days later that the blade had fractured.There was no medical intervention and it was deemed that the risk of removing the broken piece was a higher risk than to leave it inside the patient.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d1; d4; d9; g3; g6; h1; h2; h3; h6; h11.A visual inspection was conducted on the returned drive.The drive shows signs of multiple uses including heavy marking and scratching on the drive surface.The customer reported that the drive fractured.A visual inspection of the drive tip shows that the drive is intact with no evidence of fracturing.The drive base is also completely intact with no fracturing noticed as well.The gripping surface of the drive does show evidence of stripping/ twisting including marking on the gripping surface.The gripping surface is no longer aligned with the drive base and has twisted; however, the tip is still intact.A dimensional analysis was conducted, and the product measured within specification.The complaint of fracture is unable to be confirmed.The drive tip is twisted, however.Medical records were not provided.The receiving inspection records were reviewed for deviations and/or anomalies with no anomalies/deviations identified.The root cause of the reported issue is attributed to a user error.It was reported that a torque limiter was not used.Per the surgical technique for this system the torque limiter must be used.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 available at the time of this report.

• Brand Name: THE LOW PROFILE STERNAL CLOSURE SYSTEM T15 HEXALOBE DRIVE
• Common Device Name: DRIVER, PROSTHESIS
• 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: 18878122
• Report Number: 0001032347-2024-00093
• Device Sequence Number: 7919126
• Product Code: HWR
• UDI-Device Identifier: 00851599007655
• UDI-Public: (01)00851599007655(10)1122203
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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: 201.047.15
• Device Catalogue Number: 201.047.15
• Device Lot Number: 1122203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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: Male