MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET TAPER HEX SCDR RIGID; HIP INSTRUMENTS : SCREWDRIVERS

Model Number 2274-47-000

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

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

Event Type  malfunction  

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 stripped 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.

Event Description

The following device was received as blind unit.Product code: 227447000; lot# s02042366 / ag0185111.It couldn¿t be associated with a complaint or any other existing record.The product has been investigated.

• Brand Name: QUICKSET TAPER HEX SCDR RIGID
• Type of Device: HIP INSTRUMENTS : SCREWDRIVERS
• 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 ; 6107428552
• MDR Report Key: 12051787
• MDR Text Key: 263395032
• Report Number: 1818910-2021-13400
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10603295109235
• UDI-Public: 10603295109235
• 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
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2274-47-000
• Device Catalogue Number: 227447000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Date Manufacturer Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2019
• 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