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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. DRILL GUIDE HANDLE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674001
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/27/2020
Event Type  malfunction  
Event Description
It was reported that a drill guide handle was having issues clipping to the drops. No harm or injury reported on patient. Procedure was finished with a smith and nephew back up device. No delay reported.
 
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Brand NameDRILL GUIDE HANDLE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
1450 brooks road
memphis, TN 38116
MDR Report Key10841647
MDR Text Key216306000
Report Number1020279-2020-06460
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71674001
Device Catalogue Number71674001
Device Lot Number08LGT0010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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