MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 DRILL BIT; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Catalog Number 227425500

Device Problem Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

(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

Event: the 25mm flexible drill was damaged in procedure.The driller battery was discharged.The battery-related event was reported to the ed team.Drill: cod 227425500 and lot pg258730.Battery: uninformed code and batch.

Manufacturer Narrative

Product complaint # pc-(b)(4).Investigation summary the instrument associated with this report was not returned.The provided photograph confirmed the reported observation.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRILL BIT
• Type of Device: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7283658
• MDR Text Key: 100656768
• Report Number: 1818910-2018-53743
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 227425500
• Device Lot Number: PG258730
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2018
• Date Device Manufactured: 08/10/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1