MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 ROD FOR REAMING GUIDE HOLDER

Model Number 2307-74-002

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/20/2021

Event Type  malfunction  

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 Description

Initial report: very sclerotic bone rep present and followed standard surgical technique instruments damaged upon use surgical delay 5 minutes.Procedure successfully completed.No consequence to patient.Further information provided; the awl was bent.The tip of the proximal reaming handle snapped off.The proximal reaming guide was damaged upon removal as was stuck in the patient after the proximal reaming handle snapped.Had to remove with mole wrench / pliers and roughed up the ends.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with the reported event was not returned for examination.Visual examination of the provided photograph found the tip of the rod to be broken.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ROD FOR REAMING GUIDE HOLDER
• Type of Device: ROD FOR REAMING GUIDE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 11279283
• MDR Text Key: 230744284
• Report Number: 1818910-2021-02409
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295116134
• UDI-Public: 10603295116134
• Combination Product (y/n): N
• PMA/PMN Number: K170748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2307-74-002
• Device Catalogue Number: 230774002
• Device Lot Number: 5098669
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1