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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. GUIDE BOLT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71654506
Device Problem Failure to Align (2522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/17/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: case (b)(4). The device, intended for use in treatment, was returned for evaluation. A visual inspection was performed and confirmed the stated failure. The guide bolt posts are worn and damaged, the threads are also showing wear. A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes. At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture. A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number. This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur. Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event. 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 warranted for this complaint, however we will continue to monitor for future complaints and investigate as necessary. We consider this investigation closed.
 
Event Description
It was reported that, during internal fixation surgery, the surgeon stated that it was difficult to line up properly the guide bolt and a std drill guide during the case. A surgical delay of approximately 2 minutes occurred due to this issue, and a smith and nephew backup devices were available to conclude the procedure. No patient injury was reported due to this issue.
 
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Brand NameGUIDE BOLT
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12677279
MDR Text Key277952715
Report Number1020279-2021-07642
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K12217
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71654506
Device Catalogue Number71654506
Device Lot Number12LM09857
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/16/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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