MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI FEMORAL DRILL 6.35 MM 35MM

Model Number N/A

Device Problem Break (1069)

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

Event Date 01/04/2018

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

It was reported that oxford femoral drill was broken at total knee arthroplasty upon drilling subsequently alternative drill was used to complete the procedure.

Manufacturer Narrative

(b)(4).Products have been returned to (b)(4) for evaluation and forwarded to the complaints and vigilance engineer.A complaint history review was conducted for (b)(4).The search identified 6 further complaints for the same type of issue for the same lot # zb120701 between the dates of (b)(6) 2015 to (b)(6) 2018.The complaints data will be presented to the capa review board due to a trend being found as per local procedure sop-163 rev 6 - data trend analysis.A visual inspection of the instrument showed evidence of heavy wear which suggests the most likely cause of the fracture to be wear and tear.The review of the documentation has confirmed that the instrument was conforming to pre-defined drawing specification when manufactured in 2013.

• Brand Name: OXF UNI FEMORAL DRILL 6.35 MM 35MM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7215644
• MDR Text Key: 98413381
• Report Number: 3002806535-2018-00157
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• 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: 32-422845
• Device Lot Number: ZB120701
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1