MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5.0MM TI W/ MAXBRAID NDLS; FASTNER, FIXATION

Catalog Number	902571
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant fractured during the procedure.The piece was retained by the patient.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
(b)(4).G2: foreign: poland.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 report will be submitted.H3 other text : product not returned.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).Visual examination of the returned product/provided pictures identified the anchor tip is broken off.Sem images shows ductile dimples which suggests a torsional overload mode of failure.Eds semi-quantitative elemental analysis of the maxbraid needle showed that it was consistent with ti-6al-4v alloy.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is 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 or Problem Description
No additional information is available regarding the incident.

• Brand Name: 5.0MM TI W/ MAXBRAID NDLS
• Common Device Name: FASTNER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18685764
• Report Number: 0001825034-2024-00360
• Device Sequence Number: 12496119
• Product Code: HWC
• UDI-Device Identifier: 00880304009677
• UDI-Public: (01)00880304009677(17)271222(10)2487668
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K012503
• 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): 08/05/2024

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 Catalogue Number: 902571
• Device Lot Number: 2487668
• 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: 01/29/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose