MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 STD HUM PROTHESIS EXTRACTOR; EXTREMITY INSTRUMENTS : RETRACTORS

Catalog Number	ETH001
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
(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 surgeon was using the extractor to remove an implant.Once removed, noticed the threaded screw on extractor was broken in two pieces.Instrument failure only.No surgical delay.
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.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary examination of the returned device confirmed the reported breakage.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: STD HUM PROTHESIS EXTRACTOR
• Common Device Name: EXTREMITY INSTRUMENTS : RETRACTORS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7813017
• Report Number: 1818910-2018-67624
• Device Sequence Number: 13918219
• Product Code: HWB
• UDI-Device Identifier: 10603295256625
• UDI-Public: 10603295256625
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2018

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: ETH001
• Device Lot Number: 5304002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 08/27/2018; 11/29/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 09/26/2018; 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR