MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RINGLOC+ QUICK CONNECT DRILL BIT 3.2MM X 30MM STAINLESS STEEL; DRILL, BIT

Model Number N/A

Device Problem Bent (1059)

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

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

This report is number 3 of 3 mdrs filed for the same event (reference 0001825034-2016-05298, 05299, 05300).

Event Description

It was reported that the drill bit bent during surgery.No patient injury or delay in a procedure was reported as a result of the event.

Manufacturer Narrative

Concomitant medical products- 3.2mmx30mm rnglc+ acet drl bit catalog#: 31-323230 lot#: 906570, 3.2mmx30mm rnglc+ acet drl bit catalog#: 31-323230 lot#: 764220.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: RINGLOC+ QUICK CONNECT DRILL BIT 3.2MM X 30MM STAINLESS STEEL
• Type of Device: DRILL, BIT
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6215608
• MDR Text Key: 63638291
• Report Number: 0001825034-2016-05300
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 31-323230
• Device Lot Number: 906540
• Other Device ID Number: (01)00880304452442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2016
• 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 Age: 56 YR