MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN ESC LINER EXTRACTOR TIP; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Model Number 2218-00-010

Device Problem Material Deformation (2976)

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

Event Date 05/24/2022

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 while putting instruments together, the sales rep found the tip of the esc liner extractor to be bent.It is unknown when the damage occurred.Instruments are no longer functional.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: the device associated with this report was returned for analysis.Visual examination of the device confirmed, the complaint.The tip of the instrument is bent.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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINN ESC LINER EXTRACTOR TIP
• Type of Device: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14633379
• MDR Text Key: 293558487
• Report Number: 1818910-2022-10408
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295099505
• UDI-Public: 10603295099505
• 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,Followup
• Report Date: 06/08/2022

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: 2218-00-010
• Device Catalogue Number: 221800010
• Device Lot Number: NW272864
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 07/19/2022
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2021
• 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
• Patient Sex: Male