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

Catalog Number	210050015
Medical Device Problem Codes	Material Discolored (1170); Flaked (1246)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2017
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
Der states that green ring around the neck of the size 14 humeral proximal body trial fluffed off in the patient during reduction trial.All pieces were recovered.No items remained in the patient.Surgery time was delayed only by the amount of time it took to recover green color "coating" from the patient.Surgeon identified instrument error early.There may be deficiency in the design but may be stress and number of times used.Surgeon performed extensive i&d.Intra-op images are available of the prosthesis trial.
Additional Manufacturer Narrative
Review of the provided photographs confirm the reported event.The device associated with this report was not returned for evaluation.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, 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: 7159739
• Report Number: 1818910-2018-50061
• Device Sequence Number: 1274931
• Product Code: LXH
• UDI-Device Identifier: 10603295416098
• UDI-Public: 10603295416098
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 12/05/2017

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: NW148536
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR