MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM ASSEMB TOOL ADAPT 85MM; RECLAIM INSTRUMENTS : INSERTION DEVICES

Catalog Number	297500610
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.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.
Event or Problem Description
It was reported while inspecting the instruments prior to sterilization, it was found that the spring was damaged on the adapter for the assembly tool.The instrument was not used in surgery.Surgery was not extended.

• Brand Name: RECLAIM ASSEMB TOOL ADAPT 85MM
• Common Device Name: RECLAIM INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8647206
• Report Number: 1818910-2019-94642
• Device Sequence Number: 1925072
• Product Code: LXH
• UDI-Device Identifier: 10603295155966
• UDI-Public: 10603295155966
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 04/29/2019

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: 297500610
• Device Lot Number: A0111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1