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 10/24/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly.

Event Description

During a partial knee arthroplasty a drill bit fractured.The fractured piece was retained and another instrument was used to complete the procedure.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned device found heavy burring of the cutting surface, tarnished appearance from repeated reprocessing and cleaning, and black colouring penetration of the coating surface associated with excessive heat from friction.Dimensional and hardness checks were carried out and the drill bit was found to be conforming to drawing specification.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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: 6119130
• MDR Text Key: 60620439
• Report Number: 3002806535-2016-00855
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PP010014
• 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
• Report Date: 06/23/2017

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: ZB130103
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention