MAUDE Adverse Event Report: BIOMET ORTHOPEDICS FAST 1.1MM DRILLBIT MINIQUICK; BIT, DRILL

Model Number N/A

Device Problems Bent (1059); Unable to Obtain Readings (1516); Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 06/29/2015

Event Type  Injury  

Event Description

It was reported that patient underwent a hand fracture procedure on (b)(6) 2015.During the procedure, the drill bit bent.Another drill bit was attempted but cold welded to the guide.It was noted the depth gauge could not get a reading as it was sticking when hooked into the cortex.A smaller drill bit and another depth gauge was utilized to complete the procedure.Additional holes had to be drilled in the patient.

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.

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

Examination of returned device found no evidence of product non-conformance.Evaluation of the returned device found the fast guide component is cold welded to the drill bit and is unable to be removed for dimensional analysis.It was noticed that this drill bit is also bent which likely was caused by the surgeon drilling at an angle causing friction against the inside diameter of the fast guide leading to the cold welding of the two parts.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-03462 & 04124).

• Brand Name: FAST 1.1MM DRILLBIT MINIQUICK
• Type of Device: BIT, DRILL
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4958051
• MDR Text Key: 15913530
• Report Number: 0001825034-2015-03462
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 231220202
• Device Lot Number: 032166
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR