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

Model Number 2975-00-100

Device Problems Break (1069); Corroded (1131); Material Discolored (1170); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint (b)(4).Non-health care professional.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

After receiving 2 complaints about a hip kit, orthokit manager checked the build 5 in the warehouse, and saw rust on almost every part of the kit.For some parts it's also missing color codes (usually red, yellow, green, blue).This kit went to a customer in (b)(6) 2016 and was new at the time.It was checked when it came back in 2016 and was let in storage since then.

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

Manufacturer Narrative

Product complaint#: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.   h10 additional narrative: added h6 (device code).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.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.

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.

• Brand Name: RECLAIM PROX REAMER GUIDE POST
• Type of Device: RECLAIM INSTRUMENTS : ADAPTORS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7850156
• MDR Text Key: 119339490
• Report Number: 1818910-2018-68523
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295155850
• UDI-Public: 10603295155850
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/13/2018

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 Model Number: 2975-00-100
• Device Catalogue Number: 297500100
• Device Lot Number: SO2001032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 09/06/2018
• Supplement Dates Manufacturer Received: 09/25/2018; 10/07/2019; 04/23/2020; 04/23/2020
• Supplement Dates FDA Received: 10/19/2018; 10/07/2019; 04/27/2020; 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1