MAUDE Adverse Event Report: BIOMET UK LTD. OXF FEM TRIAL REMOVER; KNEE PROSTHESIS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that during the procedure it was found that the oxford slap hammer was broken in the kit.The pin would not stay attached and therefore did not work.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d10, g4, h1, h2, h6, h10.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

The pin was falling out and the instrument could not be used properly.The event occurred during the surgery.

Event Description

It was reported that during the procedure it was found that the oxford slap hammer was broken in the kit.The pin was falling out and the instrument couldn¿t be used properly.The event occurred during the surgery.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in australia.Products have been returned to biomet uk ltd for evaluation and forwarded to the complaints product evaluation engineer for investigation.Summary of investigation: visual inspection confirmed the reported event.The pin is loose.This is an early design that has been superseded.New design (32-422365) drawing specify that the pins should be welded.The pin can move but is captured within the instrument.Some usage impact marks are can be seen on both sides around the area of the pin.Except for the loose pin, which is the reported event, the rest of the instrument assembly looks and functions as to the design specifications.The most likely root cause: wear and tear over prolonged use and multiple sterilisation cycles.Mhr is not available, because eurocut does not hold the product history files produced prior to 2008.A review of the complaint database over the last 3 years found no other complaints reported against item 32-420126 and lot e9 11478 combination.There are no other similar complaints reported against the pin defects in instrument 32-420126.Risk assessment: the severity of the reported event (s-2, minor delay) is within the limits specified in the risk file.Corrective and preventive actions taken: no corrective actions have been determined, because no design or manufacturing faults have been identified.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.

• Brand Name: OXF FEM TRIAL REMOVER
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9368495
• MDR Text Key: 218525483
• Report Number: 3002806535-2019-00885
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• 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: E9 11478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1