MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 BROACH CORAIL AMT 15; HIP INSTRUMENTS : BROACHES

Catalog Number	L20415
Medical Device Problem Codes	Material Twisted/Bent (2981); Scratched Material (3020)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	04/09/2019
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 at the rod portion of the neck of the colail broach #15 (p/n l20415) was broken or deformed when the surgeon used the calcar reamer small during the surgery on (b)(6) 2019, so the surgeon could not insert the neck trial.The surgeon attempted explanting the broach however the broach handle was not able to attach, so the surgeon forcibly struck the broach handle in and connected and explanted the broach.The surgeon did a trial test with the broach #14 and confirmed there was no problem by the x-ray, implanted the stem #15.The surgery was completed within a 30 minutes delay and there was no adverse consequence to the patient.No further information is available.
Additional Manufacturer Narrative
Product complaint(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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: the device was reviewed by bioengineering and a report was received stating it was unlikely that a manufacturing defect was present root cause attributed to the device being worn from normal use and servicing.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BROACH CORAIL AMT 15
• Common Device Name: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 8573831
• Report Number: 1818910-2019-92295
• Device Sequence Number: 2039220
• Product Code: HTQ
• UDI-Device Identifier: 10603295258179
• UDI-Public: 10603295258179
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2019

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: L20415
• Device Lot Number: SO2020268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 05/10/2019; 07/01/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/06/2019; 07/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1