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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG SCREW DRIVER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. LAG SCREW DRIVER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71674067
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/09/2018
Event Type  malfunction  
Event Description
It was reported that a malfunction has occurred. Threads at the end of the item are broken. No broken piece was left in the patient or fell in the patient. No harm to the patient was recorded.
 
Manufacturer Narrative
The associated complaint device was returned and evaluated. A visual examination of the returned lag screw driver retaining rod indicated a portion of the threaded end has fractured off. The fractured portion was not returned. A review of complaint history for the part revealed no prior complaints for the listed batch. We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary. At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture. Based on this investigation, the need for corrective action is not indicated. Should additional information be received, the complaint will be reopened. We consider this investigation closed.
 
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Brand NameLAG SCREW DRIVER
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8024776
MDR Text Key125672172
Report Number1020279-2018-02313
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,health
Type of Report Initial,Followup
Report Date 12/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71674067
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2018
Is This a Reprocessed and Reused Single-Use Device? No

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