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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2022

Event Type  malfunction  

Event Description

It was reported that the following device was received as blind unit: product received at pal jrz: - product code: 227425500.- lot number: pg308486.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: a blind device with no information or any allegation was received.Examination of the returned device found a bent condition at the tip.Additionally, some marks and scratches were noted.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Component code: (b)(4).

• 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13507201
• MDR Text Key: 286476009
• Report Number: 1818910-2022-02690
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10603295109129
• UDI-Public: 10603295109129
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• 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
• Device Lot Number: PG308486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1