MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 BROACH CORAIL AMT 18; HIP INSTRUMENT/TRIAL

Catalog Number	L20418
Medical Device Problem Codes	Misconnection (1399); Connection Problem (2900)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	08/23/2017
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
Der stated that broaches can't get onto broach handle.
Additional Manufacturer Narrative
(b)(4).Investigation summary no instrument associated with this report was received for examination.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.
Event or Problem Description
Complaint description: der stated that broaches can't get onto broach handle.

• Brand Name: BROACH CORAIL AMT 18
• Common Device Name: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• MDR Report Key: 6886895
• Report Number: 1818910-2017-25226
• Device Sequence Number: 13577231
• Product Code: HTQ
• UDI-Device Identifier: 10603295258193
• UDI-Public: 10603295258193
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: L20418
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR