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U.S. Department of Health and Human Services

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

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SMITH AND NEPHEW INC GUIDE BOLT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
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.
 
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Brand NameGUIDE BOLT
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH AND NEPHEW INC
1450 brooks road
memphis TN 38116
MDR Report Key7850478
MDR Text Key119352254
Report Number1020279-2018-01727
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K122170
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received09/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71654506
Device Lot Number10JM03259
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

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