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

Catalog Number	L20418
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Hip Fracture (2349); Not Applicable (3189)
Date of Event	08/14/2017
Type of Reportable Event	Serious Injury
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 surgeon broached to a size 16 which was too small.The surgeon had no option but to try the 18 broach.This was unremarkable , however when the surgeon reduced the femur with the std neck and 32 +1 trial head in situ, there was an audible crack.Doe: (b)(6) 2017 ; surgical delay of 3 hours.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no products were returned.A search for the broach product codes identified no previous similar requests.We sent the surgeons request for the extra size broaches to our bio-engineering department who responded as follows: no immediate action is deemed necessary for the current marketed product.New product development process requires complaint review therefore this will be captured and taken in consideration in future developments.No corrective action is required if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BROACH CORAIL AMT 18
• Common Device Name: TRIAL/INSTRUMENT
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7098573
• Report Number: 1818910-2017-50993
• Device Sequence Number: 19301345
• Product Code: HTQ
• UDI-Device Identifier: 10603295258193
• UDI-Public: 10603295258193
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2017

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 03/09/2018
• 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: Other