MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANT BONE RMVL CUTTER SML; OXFORD KNEES INSTRUMENTS

Catalog Number 32-423236

Device Problem Dull, Blunt (2407)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Reamer was dull and needed replacement.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The complaint reported that the oxford anterior bone mill (part number: 32-423236; lot: zb120601) shows excessive wear and is blunt.The investigation confirmed the complaint.The product was in the field for approximately 6 years and 5 months.Therefore, the most likely cause of the defect is excessive wear over a long time period.Device history record (dhr) was reviewed and no discrepancies were found.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

It was reported that impingement reamer was dull and needed replacement.

• Brand Name: OXF ANT BONE RMVL CUTTER SML
• Type of Device: OXFORD KNEES INSTRUMENTS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8096684
• MDR Text Key: 128270375
• Report Number: 3002806535-2018-01203
• 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
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 32-423236
• Device Lot Number: ZB120601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1