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 07/23/2021

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 the liner removal tool has a bent tip.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the instrument associated with this report was not returned, but a photo was provided confirming the complaint.Depuy 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.Device history lot a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• 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
• MDR Report Key: 12266838
• MDR Text Key: 264728723
• Report Number: 1818910-2021-16805
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295099505
• UDI-Public: 10603295099505
• 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: 07/23/2021

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: 2218-00-010
• Device Catalogue Number: 221800010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 09/01/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1