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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
Model Number 72200616S
Device Problem Self-Activation or Keying (1557)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/18/2017
Event Type  malfunction  
Event Description
It was reported the device powered by itself during a rotator cuff procedure.No injuries or complications were reported as a result.
 
Manufacturer Narrative
The device was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Mdu became extremely noisy and overheated after 2 minutes of running time during functional evaluation.The complaint was not confirmed and the root cause could not be determined since the reported malfunction of ¿powers by itself¿ could not be duplicated during the functional testing process.Factors which could have contributed to the identified malfunction include internal corrosion of the gearbox.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
 
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Brand Name
SVC REPL,MDU, HAND CNTRL, PWRMX
Type of Device
SAW, 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 drive
austin, TX 78735
MDR Report Key6816592
MDR Text Key83628073
Report Number1643264-2017-00500
Device Sequence Number1
Product Code HAB
UDI-Device Identifier03596010565105
UDI-Public(01)03596010565105
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/13/2017
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 Model Number72200616S
Device Catalogue Number72200616S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/18/2017
Initial Date FDA Received08/24/2017
Supplement Dates Manufacturer Received09/12/2017
Supplement Dates FDA Received09/13/2017
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
Patient Sequence Number1
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