MAUDE Adverse Event Report: BIOMET UK LTD. OXF CMNTLS IMPLANT INSERT IMPACTOR; KNEE ARTHROPLASTY

Catalog Number 32-422097

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2022

Event Type  malfunction  

Event Description

It was reported that the knee instrument fractured upon impaction of the implant.The surgery was completed without any delay; there was no patient or user harm reported.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Foreign: canada.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record was reviewed and no discrepancies were found.The likely condition of the device when it left zimmer biomet is conforming to specification.The reported event has not been confirmed as the product has not been returned for evaluation and the dhr review could not identify any issues prior to final release.The definitive root cause of the reported event cannot be determined with the information provided 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 Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product confirms the adjuster clamp foot has come off the adjuster screw.The pin securing the adjuster foot to the adjuster screw has fractured.This design has now been superseded.The instrument exhibits indentations on the top of the main body suggesting excessive use of the toffee mallet during insertion/impaction.There is also evidence of indentations on the back side of the instrument suggesting use of the toffee mallet in the anterior to posterior direction.Device is used for treatment.The instrument has been in the field for approximately 7 years and 10 months.A definitive root cause cannot 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: OXF CMNTLS IMPLANT INSERT IMPACTOR
• Type of Device: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14631874
• MDR Text Key: 301206922
• Report Number: 3002806535-2022-00269
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00880304525672
• UDI-Public: (01)00880304525672(11)151001(10)ZB130903
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010014/S078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 32-422097
• Device Lot Number: ZB130903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/17/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 10/03/2022; 10/03/2022
• Supplement Dates FDA Received: 06/22/2022; 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1