MAUDE Adverse Event Report: BIOMET UK LTD. BEARING TRIAL WITH SLOTS, SMALL, 3MM; OXFORD MICROPLASTY INSTRUMENTS

Model Number N/A

Device Problem Material Integrity Problem (2978)

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

Event Date 06/10/2022

Event Type  malfunction  

Event Description

It was reported, that during the surgery the surgeon was trialing and when he removed the trial bearing a small part of it chipped.No delay or reported health consequences to patient.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b2, b4, b5, g3, g6, h2, h3, h6, h10.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.Visual examination of the returned product confirmed the reported fracture.A piece has broken away from the main body (piece not returned).There are signs of other damage to the trial bearing which could be attributed to its amount of use, however from visual examination, it could not be determined how the fracture was caused.Device is used for treatment.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.

• Brand Name: BEARING TRIAL WITH SLOTS, SMALL, 3MM
• Type of Device: OXFORD MICROPLASTY INSTRUMENTS
• 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: 14942193
• MDR Text Key: 303821848
• Report Number: 3002806535-2022-00285
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279346608
• UDI-Public: (01)05019279346608(11)211020(10)ZB7117729
• 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
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• 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: 32-422698
• Device Lot Number: ZB7117729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• 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