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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SELF HOLDING HEX SCREWDRIVER; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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SMITH & NEPHEW, INC. SELF HOLDING HEX SCREWDRIVER; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 71110026
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/29/2018
Event Type  malfunction  
Event Description
It was reported that during surgery, the self-retaining part of hex driver (shaft) snapped.A backup device was available to complete the procedure with no delay or patient injuries.
 
Manufacturer Narrative
The associated self holding hex screwdriver was not returned for evaluation.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.
 
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Brand Name
SELF HOLDING HEX SCREWDRIVER
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8192325
MDR Text Key131304649
Report Number1020279-2018-02880
Device Sequence Number1
Product Code HRY
UDI-Device Identifier03596010173034
UDI-Public03596010173034
Combination Product (y/n)N
PMA/PMN Number
K121393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/15/2019
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 Catalogue Number71110026
Initial Date Manufacturer Received 11/29/2018
Initial Date FDA Received12/21/2018
Supplement Dates Manufacturer Received11/29/2018
Supplement Dates FDA Received02/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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