MAUDE Adverse Event Report: SMITH AND NEPHEW INC GUIDE BOLT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71654506

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2018

Event Type  malfunction  

Event Description

It was reported a malfunction in which the bolt that fixes the nail to external targeter broke during insertion of the nail into the medullary canal, then extracted the nail, removed part of the broken bolt, reassembled nail on targeter with second bolt supplied to urbino and then reinserted the nail.Ten minutes delay reported.

Manufacturer Narrative

The associated guide bolt was not returned for evaluation.The device was manufactured in 2010.Our investigation including a review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GUIDE BOLT
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH AND NEPHEW INC; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7850478
• MDR Text Key: 119352254
• Report Number: 1020279-2018-01727
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010585868
• UDI-Public: 03596010585868
• Combination Product (y/n): N
• PMA/PMN Number: K122170
• 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: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71654506
• Device Lot Number: 10JM03259
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1