MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM REAMER EXTRACT ADAPTOR; RECLAIM INSTRUMENTS : IMPACTION INSTRUMENTS

Model Number	2975-00-910
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
During hip revision surgery at (b)(6) hospital on monday (b)(6) 2020 it was not possible to separate the following two reclaim instruments after they had been used to remove a distal reamer.Surgeon was mr (b)(6).297500800 reclaim distal stem inserter, lot so2034382; 297500910 reclaim reamer extract adaptor, lot so2042156.After approximately 10 minutes of trying to separate the instruments the surgeon gave up and had to complete the rest of the operation without the distal stem inserter.
Additional 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.H10 additional narrative: added: h6 (patient codes).H6 patient code: no code available (3191) used to capture the surgery prolonged and insufficient information.Product complaint (b)(4).Investigation summary: examination of the returned instrument cannot confirm 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RECLAIM REAMER EXTRACT ADAPTOR
• Common Device Name: RECLAIM INSTRUMENTS : IMPACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10111387
• Report Number: 1818910-2020-13023
• Device Sequence Number: 11716702
• Product Code: HWR
• UDI-Device Identifier: 10603295156185
• UDI-Public: 10603295156185
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2975-00-910
• Device Catalogue Number: 297500910
• Device Lot Number: SO2042156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1