MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS INSERTER EXTRACTOR; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Catalog Number 298772030

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed 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.

Event Description

It was reported that button found to be damaged in post cleaning inspection.Will not operate properly.No surgical delay.

• Brand Name: LPS INSERTER EXTRACTOR
• 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 ; 1210 ward avenue; west chester, PA 19380 ; 6107428552
• MDR Report Key: 9262543
• MDR Text Key: 187195427
• Report Number: 1818910-2019-113471
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295159131
• UDI-Public: 10603295159131
• 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: 10/29/2019

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 Catalogue Number: 298772030
• Device Lot Number: SO2025876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2016
• 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