MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTRAMEDULLARY TIBIAL RESECTION CUT GUIDE LEFT; INSTRUMENT, KNEE

Model Number	42-5870-002-01
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical product: headless trocar drill pin 3.2 mm diameter 75 mm length: catalog#00590102000, lot#ni.Multiple mdr reports have been filed for this event, please see associated report: 0001822565-2022-00872.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
It was reported that during a left knee procedure, a drill pin cold welded to the resection guide.The drill pin later fractured when attempting to remove it from the guide after surgery.There was no surgical delay or patient impact and the procedure was able to proceed without further incident.Attempts have been made and no further information has been made available.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified that a trocar pin has seized in a guide hole of the cut guide.The trocar pin was found to also be broken with no lot identification visible.Both items exhibits signs of repeated use and the cut guide had guide holes scratched and one slot had burrs.Device history record was reviewed and no discrepancies related to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Root cause was unable to 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.

• Brand Name: INTRAMEDULLARY TIBIAL RESECTION CUT GUIDE LEFT
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13938025
• Report Number: 0001822565-2022-00873
• Device Sequence Number: 20478271
• Product Code: JWH
• UDI-Device Identifier: 00889024558861
• UDI-Public: (01)00889024558861(10)64363339
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K181947
• 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,Followup
• Report Date (Section B): 04/08/2022

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 Model Number: 42-5870-002-01
• Device Catalogue Number: 42587000201
• Device Lot Number: 64363339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• 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: 03/08/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2019
• 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
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female