MAUDE Adverse Event Report: DEPUY IRELAND 961610 UNIVERSAL STEM INSERT HANDLE; HIP INSTRUMENTS : HANDLES

Catalog Number 259807460

Device Problems Mechanical Problem (1384); Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2017

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 handle does not release the stem impactor easily.It is damaged internally at the connection.

Manufacturer Narrative

Product complaint # pc-(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNIVERSAL STEM INSERT HANDLE
• Type of Device: HIP INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY IRELAND 961610 ; loughbeg ringaskiddy; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7757876
• MDR Text Key: 116265122
• Report Number: 1818910-2018-65943
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295148449
• UDI-Public: 10603295148449
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

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: 259807460
• Device Lot Number: PG260744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1