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

Model Number	2975-00-605
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2020
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
It was reported that the 75 mm proximal body adapter for the reclaim assembly tool is missing an o-ring.We need a replacement sent to us.We were still able to use the 75 mm adapter with no issues.The surgery was completed successfully.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the instrument associated with this report was not returned.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 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: 10224305
• Report Number: 1818910-2020-14921
• Device Sequence Number: 2565529
• Product Code: LXH
• UDI-Device Identifier: 10603295155959
• UDI-Public: 10603295155959
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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: SO2000054
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1