MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 BROACH CORAIL AMT 14; HIP INSTRUMENTS : BROACHES

Catalog Number L20414

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of the returned instrument confirmed the complaint.Depuy 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.The instrument associated with this report was not returned.Depuy 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.The instrument associated with this report was not returned.With no instrument returned and no more information, no root cause can be determined for this specific instrument.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under post market surveillance sep 419.Update: march 21,2019.Territory 226 reported that the corail 14 broach has worn down on the broach to inserter connection.The broach will not engage to a calcar planner, broach handle, or a trial neck.This broach needs to be replaced.There was no surgical delay.Examination of the returned instrument confirmed the complaint; deep circular scratching was found on the taper preventing from engaging correctly with mating instruments.A functional check with a broach handle confirmed the broach will not assemble correctly with the handle.A search of the complaint database found similar complaints that attributed the root cause to be from misuse.Deep circular scratching is due to the taper not being seated all the way into the broach handle before locking down on the lever locking mechanism of the broach handle.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under post market surveillance sep 419.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the corail 14 broach has worn down on the broach to inserter connection.The broach will not engage to a calcar planner, broach handle, or a trial neck.This broach needs to be replaced.There was no surgical delay.

• Brand Name: BROACH CORAIL AMT 14
• Type of Device: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward av; b.p. 256; west chester, PA 19380 ; 6107428552
• MDR Report Key: 8486795
• MDR Text Key: 141037150
• Report Number: 1818910-2019-89904
• Device Sequence Number: 1
• Product Code: HTQ
• UDI-Device Identifier: 10603295258162
• UDI-Public: 10603295258162
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: L20414
• Device Lot Number: SO2024030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1