MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET 1PC FLEX DRILL BIT 25; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Model Number 2274-25-500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the driver tip broke off in screw head and the drill bit broke while drilling.Surgical delay of 4 minutes.

Event Description

Additional information received that instruments were broken into two pieces.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the instrument associated with this report was not returned.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot null device history batch null device history review null.

• Brand Name: QUICKSET 1PC FLEX DRILL BIT 25
• Type of Device: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9845758
• MDR Text Key: 191000502
• Report Number: 1818910-2020-08384
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10603295109129
• UDI-Public: 10603295109129
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2274-25-500
• Device Catalogue Number: 227425500
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 03/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1