MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN HEADLESS TROCAR DRILL PIN 3.2 MM DIAMETER 75 MM LENGTH; INSTRUMENT, KNEE

Catalog Number	00590102000
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products: 42509901000 - distal cut block - 64877004.Visual examination of the returned product identified signs of use (scratches and gouges).Pin is fractured (not all returned) and stuck in the guide.Dimensional analysis of the product determined that the product, where measured, was conforming to its print specifications.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Complaint is confirmed based on product evaluation.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
It was reported that during a knee arthroplasty, the pin got stuck in the cutting block hole.There was no consequences or impact to the patient.

• Brand Name: NEXGEN HEADLESS TROCAR DRILL PIN 3.2 MM DIAMETER 75 MM LENGTH
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22531870
• Report Number: 0001822565-2025-02583
• Device Sequence Number: 8017948
• Product Code: LXH
• UDI-Device Identifier: 00889024201620
• UDI-Public: (01)00889024201620(17)340626(10)66552612
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2025

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: 00590102000
• Device Lot Number: 66552612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2025
• 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: 07/16/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Male