MAUDE Adverse Event Report: DEPUY IRELAND 961610 RECLAIM ASSEM UPPER PULL ROD; RECLAIM INSTRUMENTS : INSERTION DEVICES

Catalog Number	297500635
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2018
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
The tip broke due to bad effort or system failure.
Additional Manufacturer Narrative
Product complaint #: (b)(4).
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).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RECLAIM ASSEM UPPER PULL ROD
• Common Device Name: RECLAIM INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY IRELAND 961610 ; loughbeg ringaskiddy; cork ; EI
• MDR Report Key: 7756219
• Report Number: 1818910-2018-65855
• Device Sequence Number: 13790803
• Product Code: HWB
• UDI-Device Identifier: 10603295155942
• UDI-Public: 10603295155942
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/11/2018

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 Catalogue Number: 297500635
• Device Lot Number: SO2030267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/16/2018; 10/09/2018; 11/07/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 08/17/2018; 10/24/2018; 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1