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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. PERCUTANEOUS GUIDE BOLT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71631024
Device Problem Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/27/2019
Event Type  malfunction  
Event Description
It was reported that during surgery the surgeon was performing a metatan nail and he tried to insert the set screw through the proximal jig and got the set screw stuck in the bolt. He managed to eventually remove the set screw but it was attached to the bolt and the bolt is now stuck to the set screw. No injury was reported. A delay greater than 30 minutes was reported.
 
Manufacturer Narrative
The associated device was returned and evaluated. A visual inspection of the returned device confirmed the stated failure mode. A setscrew was stuck in the guide bolt and could not be removed. The device was manufactured in 2015 and exhibits signs of extensive wear / usage. Per the surgical technique, the guide bolt should be removed before the setscrew can be inserted. A review of complaint history did not reveal additional complaints for the listed batch. A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident. At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture. We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary. Based on this investigation, the need for corrective action is not indicated. Should additional information be received, the complaint will be reopened. No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
 
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Brand NamePERCUTANEOUS GUIDE BOLT
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key9247520
MDR Text Key164334157
Report Number1020279-2019-03746
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71631024
Device Lot Number15MM11208
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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