MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL BROACH HANDLE; CORAIL KAR INSTRUMENTS : HANDLES

Model Number 9522-11-500

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

While doing hip arthroplasty,broach got stock in femur.Surgeon used slap hammer attached to broach handle to remove broach.The screw attachment on the slap hammer broke and stayed stuck into broach handle.They used a second broach handle and slap hammer, same thing happened but at least the broach came out this time.During the same surgery, the poly trial also broke, 2 little pieces came off the trial.Both pieces were removed without any problems.No patient harm although all these problems, but surgery was delayed by at least 30 minutes.Pls replace following instr.Asap, bill to (b)(4), ship to (b)(4), po: (b)(4), 2 ea (b)(4), 1 ea (b)(4), 1 ea (b)(4).Patient consequence? :no.

Manufacturer Narrative

Product complaint #
=
> pc-(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: h6 (device code).The previous reported device code (break) is being retracted since it was incorrectly submitted in the initial medwatch.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: CORAIL BROACH HANDLE
• Type of Device: CORAIL KAR INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7573684
• MDR Text Key: 110230807
• Report Number: 1818910-2018-61494
• Device Sequence Number: 1
• Product Code: HTQ
• UDI-Device Identifier: 10603295230663
• UDI-Public: 10603295230663
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9522-11-500
• Device Catalogue Number: 952211500
• Device Lot Number: CY1005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention