MAUDE Adverse Event Report: BIOMET UK LTD. ACCU-LINE QUICK RELEASE DRILL BIT 1/8 IN. (3.2MM); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

During a right partial knee arthroplasty a drill bit fractured during extraction while using the drill bit remover.The fractured piece was retained by the patient but does not need to be removed according to the surgeon.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the drill confirmed it had snapped.The drill bit was heavily indented, from multiple use.The chuck end on the drill bit was badly marked from use, and the shaft of the drill was heavily tarnished from repeated cleaning and reprocessing.The fracture point was burred and uneven.The investigation has taken into consideration the age and condition of the instrument, which has concluded the drill bit failure was due to wear and tear from excessive use during the 7 years of service.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.

• Brand Name: ACCU-LINE QUICK RELEASE DRILL BIT 1/8 IN. (3.2MM)
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: daniel tilbury ; waterton industrial estates; bridgend ; 0441656655
• MDR Report Key: 6119083
• MDR Text Key: 60622380
• Report Number: 3002806535-2016-00854
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 32-467619
• Device Lot Number: ZB090721
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2009
• 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
• Patient Outcome(s): Disability