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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN DRILL GUIDE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. META-TAN DRILL GUIDE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71631451
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/17/2018
Event Type  Injury  
Manufacturer Narrative
The associated complaint devices were returned and evaluated. A visual inspection of the returned meta-tan drill guide confirms the stated failure. The device is fractured at handle/femoral wings connection. From the analysis conducted during this investigation, it was concluded that the drill guide handle portion fractured mostly likely due to overload. An overload fracture can occur if the mechanical loads applied to the drill guide exceeded the strength of the material. It is likely the fracture initiated due to repeated impact strikes during repeated nail insertion use. It was unknown if the fracture in the drill guide handle was initiated in a prior surgery. The device exhibits signs of repeated use and significant wear. A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes. The clinical/medical team concluded, it was reported that there was a crack in the metatan targeter, resulting in a procedural delay. No patient injury was sustained as a result of this device related incident aside from the extended surgery time, and the procedure was completed successfully. No further medical assessment is warranted based on the information provided. If new information is received in the future, this complaint can be re-opened. We consider this investigation closed.
 
Event Description
It was reported a delay in surgery above 30 minutes since dr. Had to use vice grips to target correctly the screws through the nail.
 
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Brand NameMETA-TAN DRILL GUIDE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
markus poettker
1450 brooks road
memphis, TN 38116
MDR Report Key7265854
MDR Text Key107401367
Report Number1020279-2018-00164
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71631451
Device Lot Number15KSP0010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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