MAUDE Adverse Event Report: BIOMET UK LTD. OXF CMNTLS IMPLANT INSERT; BMET GENERAL KNEE INSTRUMENTS

Model Number N/A

Device Problem Use of Device Problem (1670)

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

Event Date 02/10/2022

Event Type  malfunction  

Event Description

(b)(6) 2022.It was reported, that: loan oxford microplasty kit sent out with broken instruments inset.Item 32-422097 lot zb170602.This was only discovered during surgery.No harm to the patient, no delay.

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).He client has indicated that the product is in process of being returned to zimmer biomet for an investigation.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.

Event Description

It was reported, that: a loan oxford microplasty kit was sent out with broken instruments within the set.Item 32-422097, lot zb170602.This was only discovered during surgery.No harm to the patient, no delay.Addi 14 feb 2022.The instrument was broken when it was delivered to the hospital.There is no information as to how this happened as this is a loan kit and it was broken elsewhere.The surgeon had to place the implant by hand and impact it with the impactor listed below.32-420932.Oxford uni ph3 tibial impactor.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: adequate photographs have not been provided and the product has not been returned for evaluation.Therefore, the investigation has been limited to the information provided, a review of the device history records, and a complaint history search.A review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.A review of complaint history identified additional 47 similar (functional issues used as failure mode is unknown) complaints about the reported item and 1 additional complaint about the reported item and lot combination.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.It has been confirmed that the instrument is not within the scope or subject of any field actions or recalls which could be attributed to the reported events.The likely condition of the device when it left zimmer biomet is conforming to the specification.The reported event has not been confirmed as relevant photographs have not been provided and the product has not been returned for evaluation and the dhr review did not identify any issues.The 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 submitted accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF CMNTLS IMPLANT INSERT
• Type of Device: BMET GENERAL KNEE 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: 13523605
• MDR Text Key: 288284560
• Report Number: 3002806535-2022-00067
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• 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: 32-422097
• Device Lot Number: ZB170602
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/16/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1