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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN COMP SCREW DRIVER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. META-TAN COMP SCREW DRIVER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71631444
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/26/2018
Event Type  malfunction  
Event Description
During insertion of the compression screw, the tip of the hex driver broke off.Completed the case with backup instrument.The driver was discarded by hospital (b)(6)before our rep could retrieve it.
 
Manufacturer Narrative
The associated complaint device was not returned for evaluation.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
 
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Brand Name
META-TAN COMP SCREW DRIVER
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8174774
MDR Text Key130691724
Report Number1020279-2018-02821
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,user f
Type of Report Initial,Followup
Report Date 06/02/2019
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 Number71631444
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/26/2018
Initial Date FDA Received12/18/2018
Supplement Dates Manufacturer Received11/26/2018
Supplement Dates FDA Received06/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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