MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PROXIMAL REAMER 24MM; RECLAIM INSTRUMENTS : REAMERS

Model Number 2975-24-105

Device Problem Peeled/Delaminated (1454)

Patient Problem Insufficient Information (4580)

Event Date 09/24/2020

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

Reclaim hip revision.(b)(6) 2020.During reaming of the proximal body the loose parts of the couloured rings were noticed.They used extra pulse lavage to decrease the risk of parts in the patient.

Manufacturer Narrative

Product complaint # (b)(4).Corrected: b9: date devices returned.H3: device evaluation information.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Corrected: b9: date devices returned.H3: device evaluation information.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy-synthes 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 PROXIMAL REAMER 24MM
• Type of Device: RECLAIM INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11024750
• MDR Text Key: 222040872
• Report Number: 1818910-2020-27126
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295156239
• UDI-Public: 10603295156239
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2975-24-105
• Device Catalogue Number: 297524105
• Device Lot Number: SO2006676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2020
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1