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 Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint#: (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Visual exam found the tip deformed/bent.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

It was reported that the t handle was cracked, the extractor tips were damaged, and glue in punch.These instruments were found when set was returned to the office for inspection.

• 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: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10662773
• MDR Text Key: 210872251
• Report Number: 1818910-2020-21938
• 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
• Type of Report: Initial
• Report Date: 09/03/2020

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: NW218829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2018
• 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