MAUDE Adverse Event Report: DEPUY IRELAND 9616671 RECLAIM ASSEMB TOOL ADAPT 75MM; RECLAIM INSTRUMENTS : INSERTION DEVICES

Model Number	2975-00-605
Medical Device Problem Codes	Component Missing (2306); Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Reclaim instrument's spring unlodged during cleaning and so requires replacement.Pinnacle screw driver's black material is degrading and so requires replacement.Pinnacle drill bit is no longer sharp and requires replacement.Please ship all 3 on (b)(6).Patient consequence? no.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.
Additional 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.
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 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.Device history lot null device history batch null device history review null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RECLAIM ASSEMB TOOL ADAPT 75MM
• Common Device Name: RECLAIM INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7620913
• Report Number: 1818910-2018-62735
• Device Sequence Number: 1799484
• Product Code: LXH
• UDI-Device Identifier: 10603295155959
• UDI-Public: 10603295155959
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/30/2018

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
• Operator of Device: Health Professional
• Device Model Number: 2975-00-605
• Device Catalogue Number: 297500605
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 07/20/2018; 07/10/2019; 05/06/2020
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 08/09/2018; 07/15/2019; 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1