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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS SYNTHS QUCK CON DRL SM BAT HNDPC SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. DYONICS SYNTHS QUCK CON DRL SM BAT HNDPC SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72204124
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during an ulnar pinning procedure, the drill bit would not rotate. A competitor's device was used to complete the procedure. No patient injury or complications were reported.
 
Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question will not be returned for evaluation. Thus, the complaint could not be verified and a root cause could not be determined with confidence. It is difficult to perform an accurate evaluation of a failure without having the failed product to look at. As such the complaint is being closed without conclusion. However, if the product is returned in the future the complaint can be reopened and evaluated. Our quality department will continue to monitor for trends. No further investigation is required. (b)(4).
 
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Brand NameDYONICS SYNTHS QUCK CON DRL SM BAT HNDPC
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer (Section G)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer Contact
james gonzales
150 minuteman road
andover, MA 01810
5123585706
MDR Report Key5706293
MDR Text Key46805148
Report Number3003604053-2016-00022
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
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 05/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72204124
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2016
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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