MAUDE Adverse Event Report: DEPUY IRELAND 9616671 RECLAIM DISASMBLY THREADED CAP; RECLAIM INSTRUMENTS : EXTRACTION INSTRUMENTS

Catalog Number	297500710
Medical Device Problem Codes	Difficult to Remove (1528); Fitting Problem (2183); Connection Problem (2900); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Upon routine inspection of the reclaim disassembly instrument set, i noticed that the threaded cap was damaged and would not thread into the disassembly body.Upon inspection, i noticed that one of the threads is damaged and that there is a sharp metal edge that is protruding and preventing the cap from being tightened on to the disassembly body.
Additional 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the reported observation.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 DISASMBLY THREADED CAP
• Common Device Name: RECLAIM INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8420003
• Report Number: 1818910-2019-87240
• Device Sequence Number: 19393673
• Product Code: LXH
• UDI-Device Identifier: 10603295156079
• UDI-Public: 10603295156079
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 297500710
• Device Lot Number: J1010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 04/04/2019; 05/24/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/29/2019; 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1