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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREWDRIVER RELEASE HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. SCREWDRIVER RELEASE HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674084
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2020
Event Type  malfunction  
Event Description
It was reported that item broke during surgery.It is unknown if device was inside the patient.The procedure was completed without delay using an smith & nephew backup device.
 
Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirms the tip has piece broken off.The broken piece was not returned with the device.The device exhibits signs of significant use and wear.This instrument was manufactured in 2015.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and 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.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.
 
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Brand Name
SCREWDRIVER RELEASE HANDLE
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10437887
MDR Text Key203879268
Report Number1020279-2020-04141
Device Sequence Number1
Product Code HSB
UDI-Device Identifier03596010560810
UDI-Public03596010560810
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 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number71674084
Device Catalogue Number71674084
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2020
Initial Date Manufacturer Received 07/30/2020
Initial Date FDA Received08/21/2020
Supplement Dates Manufacturer Received09/12/2020
Supplement Dates FDA Received09/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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