MAUDE Adverse Event Report: BIOMET UK LTD. OXF FEM TRIAL REMOVER VER; BMET GENERAL KNEE INSTRUMENTS

Model Number N/A

Device Problem Mechanical Problem (1384)

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

Event Date 05/03/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report: report source, foreign - event occurred in (b)(6).The product has been requested to be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the spring inside the device is loose and cannot perform properly to remove the trial during the surgery.No harm was done to the patient and the procedure was completed without any delay.

Event Description

It was reported that the spring inside the device is loose and cannot perform properly to remove the trial during the surgery.No harm was done to the patient and the procedure was completed without any delay.

Manufacturer Narrative

(b)(4).Complaint summary: as the product has not been received, the investigation was limited to the information provided and complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records could not be performed as lot number is unknown.A review of the complaint database over the last 3 years has found 7 complaints reported with the item 32-420126 (including initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.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.H3 other text : product location unknown.

Event Description

It was reported that the spring inside the device is loose and cannot perform properly to remove the trial during the surgery.No harm was done to the patient and the procedure was completed without any delay.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information following evaluation of the returned product.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h4, h6, h10.The spring inside the device is loose and cannot perform properly to remove the trial during the surgery.No harm was done to the patient and they were able to finish the surgery without any delay.A visual check of the returned product oxford femoral trial remover (item 32-420126, lot.Zb041112) confirms that the pin holding the spring has become loose and the spring allowing the spring to become detached.A dimensional inspection is not required for this event as this reported event is for a loose spring.The most likely cause is wear and tear as there is evidence of wear and damage on all the surfaces, this suggests that this instrument has been used for many procedures since it was manufactured in 2004, therefore for this event the most likely root cause of the spring becoming loose is wear and tear due to use over the 17 years in the field, ref.Reusable instrument lifespan manual 1219.4-glbl-en-issue date 2021-04-08 this product left zimmer biomet control conforming.Investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and further investigated.

Manufacturer Narrative

(b)(4).This follow report is being submitted to relay additional information.Product has been returned and lot number has been identified.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the spring inside the device is loose and cannot perform properly to remove the trial during the surgery.No harm was done to the patient and the procedure was completed without any delay.

• Brand Name: OXF FEM TRIAL REMOVER VER
• 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: 11824170
• MDR Text Key: 261687771
• Report Number: 3002806535-2021-00195
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/18/2021

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: 32-420126
• Device Lot Number: ZB041112
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 06/30/2021; 10/20/2021; 11/18/2021
• Supplement Dates FDA Received: 07/01/2021; 10/21/2021; 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2004
• 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