MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET 1PC FLEX DRILL BIT 35; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Model Number 2274-35-500

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

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 all pieces were retrieved and returned.No surgical delay.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : as there was no reported failure, no confirmation of failure could occur but upon physical review of the instrument a bent/deformed condition was identified.Depuy-synthes 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.

• Brand Name: QUICKSET 1PC FLEX DRILL BIT 35
• 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: 11670375
• MDR Text Key: 245538801
• Report Number: 1818910-2021-07955
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10603295109174
• UDI-Public: 10603295109174
• 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: 04/14/2021

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: 2274-35-500
• Device Catalogue Number: 227435500
• Device Lot Number: PG269229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1