MAUDE Adverse Event Report: DEPUY IRELAND 9616671 RECLAIM PROX REAMER GUIDE POST; RECLAIM INSTRUMENTS : ADAPTORS

Catalog Number 297500100

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Der states that the guide post wouldn¿t properly thread into the distal reclaim stem, and the surgeon felt it damaged the threads inside the stem.The assembly tool also wouldn¿t thread into the distal stem properly, so the surgeon decided to put in a new distal stem.The 18x140 was compromised and couldn¿t be used.No surgical delay.

Manufacturer Narrative

Investigation summary: the instrument associated with this report was not returned.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 PROX REAMER GUIDE POST
• Type of Device: RECLAIM INSTRUMENTS : ADAPTORS
• 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: 7424706
• MDR Text Key: 105255262
• Report Number: 1818910-2018-57215
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295155850
• UDI-Public: 10603295155850
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 297500100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2018
• 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
• Patient Outcome(s): Required Intervention