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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616S
Device Problems Circuit Failure (1089); Device Operates Differently Than Expected (2913); Electronic Property Issue (2928)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/20/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that during review of the device a short circuit was detected.
 
Manufacturer Narrative
A complaint of ¿short circuit detected¿ error could not be reproduced. Mdu could not be functionally tested due to multiple broken connector pins on cord connector and the entire button assembly is missing from the housing. Mdu was received in this state. Mdu failed for hand piece sensor error when connected to the test control unit due to missing pins. The gearbox will not rotate and appears jammed. A review of the manufacturing records shows that this unit was released to distribution on or about (b)(6) 2016. Based on the physical evidence, the complaint investigation has concluded that this unit has succumbed to physical damage inconsistent with normal use. No containment or corrective actions are recommended at this time.
 
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Brand NameSVC REPL,MDU, HAND CNTRL, PWRMX
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
jim gonzales
7000 w. william cannon
austin, TX 78735
MDR Report Key6597599
MDR Text Key76273262
Report Number1643264-2017-00297
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,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200616S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2017
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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