MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 BROACH CORAIL AMT 16; HIP INSTRUMENTS : BROACHES

Model Number	L20416
Medical Device Problem Codes	Device-Device Incompatibility (2919); Scratched Material (3020)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/06/2020
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.(b)(4).
Event or Problem Description
It was reported that the surgeon performed a direct anterior approach total hip replacement on the left side with a pinnacle cup and a corail stem.The surgeon broached up to a size 16 corail broach.When he wanted to calcar plane, he realized the calcar planer did not seat fully over the nub on the broach.After opening another tray with another calcar planer, it was determined that something must be wrong with the size 16 corail broach.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy-synthes considers the investigation closed at this time.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: BROACH CORAIL AMT 16
• Common Device Name: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 9741990
• Report Number: 1818910-2020-05733
• Device Sequence Number: 18921246
• Product Code: HTQ
• UDI-Device Identifier: 10603295258186
• UDI-Public: 10603295258186
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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 Model Number: L20416
• Device Catalogue Number: L20416
• Device Lot Number: SO2034212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR