MAUDE Adverse Event Report: DEPUY IRELAND 9616671 RECLAIM DISASSEMBLY PUSHROD; RECLAIM INSTRUMENTS : EXTRACTION INSTRUMENTS

Catalog Number 297500720

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

(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

The rod´s tip is bent.No adverse patient consequence, no surgery delay.

Manufacturer Narrative

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

Manufacturer Narrative

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, a follow-up medwatch will be filed as appropriate. .

• Brand Name: RECLAIM DISASSEMBLY PUSHROD
• Type of Device: RECLAIM INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7302248
• MDR Text Key: 101169641
• Report Number: 1818910-2018-54221
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295156093
• UDI-Public: 10603295156093
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2018

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: 297500720
• Device Lot Number: SO2002387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 03/15/2018; 08/14/2018
• Supplement Dates FDA Received: 03/20/2018; 09/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2012
• 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