MAUDE Adverse Event Report: BIOMET UK LTD. OXF TRL BRG W/SLOTS MED 3MM; KNEE INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign - (b)(6).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that during the surgery when the surgeon was trialing, the bearing trial chipped.No pieces felt in patient.No harm reported.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified that on the bottom of the trial bearing there are two large fractures either side with missing pieces where the slot for the handle is machined.There is one of the missing fragments is shown in the photo but the other is not present.The item has score marks and dings and dents consistent with multiple usage.Lot identification is necessary for review of device history records; lot identification was not provided.Device is used for treatment.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 report 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

(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified that there are two large fractures on the bottom surface.The fractures are on both sides where the slot for the handle is machined.The trial bearing has score marks and dings and dents consistent with multiple usage.Review of the device history records identified no deviations or anomalies during manufacturing.Devices is used for treatment.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF TRL BRG W/SLOTS MED 3MM
• Type of Device: KNEE INSTRUMENT
• 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: 15622581
• MDR Text Key: 302580826
• Report Number: 3002806535-2022-00426
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279346813
• UDI-Public: (01)05019279346813(11)191202(10)ZB6682990
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010014
• 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: 01/17/2023

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 Model Number: N/A
• Device Catalogue Number: 32-422703
• Device Lot Number: ZB6682990
• 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: 09/20/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 11/23/2022; 01/09/2023
• Supplement Dates FDA Received: 12/15/2022; 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose