MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.0MM TI W/ MAXBRAID NDLS; SCREW, FIXATION, BONE/SPORTS MEDICINE

Catalog Number	902569
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the surgeon has implanted the implant and was verifying the insertion the surgeon observed that the edges of the implant fractured.The surgeon was able to remove the fractured edges and attempted to implant a second time but was unable to implant the implant.A second implant was used successfully.Multiple attempts have been made to obtain additional information; no response has been received.
Additional Manufacturer Narrative
(b)(4).G2: foreign: colombia.H3: product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.Visual examination of the returned product identified the threads on one of the anchors have fractured off.Product was sent for further analysis.Shear ductile overload dimples were identified in multiple areas on the fracture surface suggesting the screw anchor was fractured due to shear ductile overload mode.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were 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.

• Brand Name: 3.0MM TI W/ MAXBRAID NDLS
• Common Device Name: SCREW, FIXATION, BONE/SPORTS MEDICINE
• 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: 18420838
• Report Number: 0001825034-2023-03089
• Device Sequence Number: 20876282
• Product Code: HWC
• UDI-Device Identifier: 00880304432093
• UDI-Public: (01)00880304432093(17)271226(10)0002487690
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K080088
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 902569
• Device Lot Number: 0002487690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2022
• 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
• Patient Sex: Male