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 Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: the device associated with this report was returned.Examination of the returned device found evidence of wear.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.

Event Description

Devices 1 and 2: reported to be part of complaint - (b)(4).Sales rep - (b)(6).Complaint age - 91 days (usa) issues - 1 lot code mismatch, 1 extra product.Product codes - 227447000 (x2).Lot codes - so2029518 and ag0310.Received at cg labs - on (b)(6) 2021 with tracking number 285687097462.Shipped from cgl to (b)(4) - on (b)(6) 2021 with tracking number 543572863782.Shipped from (b)(4) - (b)(6) 2021 with tracking number 775250501166.Decontamination run - not available.

• 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 46581-0988 ; 6107428552
• MDR Report Key: 13540919
• MDR Text Key: 289448798
• Report Number: 1818910-2022-02907
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10603295109235
• UDI-Public: 10603295109235
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2274-47-000
• Device Catalogue Number: 227447000
• Device Lot Number: SO2029518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2017
• 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