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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HUMERAL NAIL IMPACTOR; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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SMITH & NEPHEW, INC. HUMERAL NAIL IMPACTOR; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71751133
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/18/2019
Event Type  malfunction  
Event Description
It was reported that during surgery on tightening, the head of the impactor just fell off which complicated the case.A backup device was available.More than 30 minutes delay was reported.
 
Manufacturer Narrative
The associated complaint devices were not returned.A review of the provided pictures of the drop and driver confirmed the stated failure.The drop was missing the tightening screw and the strike plate on the driver fractured off at the weld joint.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records for the listed batch did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and or device information, our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re opened.
 
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Brand Name
HUMERAL NAIL IMPACTOR
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8595183
MDR Text Key144559390
Report Number1020279-2019-01833
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 11/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number71751133
Device Lot NumberUNKNOWN
Date Manufacturer Received04/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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