MAUDE Adverse Event Report: DEPUY IRELAND 9616671 GLOBAL UNITE TR BODY SZ14 135; EXTREMITY INSTRUMENTS : PROXIMAL BODY TRIALS

Catalog Number	210050015
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2018
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
It was reported that upon retrieving instruments from the washer sterilizer the day following the surgery, they noticed one of the neck segments lost its colored ring.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.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: GLOBAL UNITE TR BODY SZ14 135
• Common Device Name: EXTREMITY INSTRUMENTS : PROXIMAL BODY TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7569495
• Report Number: 1818910-2018-61382
• Device Sequence Number: 19421826
• Product Code: LXH
• UDI-Device Identifier: 10603295416098
• UDI-Public: 10603295416098
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2018

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: 210050015
• Device Lot Number: NW148537
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR