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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC.; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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ARTHREX, INC.; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Device Problems Overheating of Device (1437); Smoking (1585); Protective Measures Problem (3015)
Patient Problem Insufficient Information (4580)
Event Date 03/04/2022
Event Type  malfunction  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event Description
On (b)(6) 2022, it was reported by a distributor via sems that while using the ar-8305 shaver console, the handpiece started to heat almost smoking, and displayed error code c34.This was discovered during use in a procedure.Requested additional information.Additional information provided (b)(6) 2022: it was reported by a distributor via email that while using the ar-8305 shaver console, the handpiece was heating the surgeon hand, and displayed error code c34.This was discovered during use in a rotator cuff repair procedure on (b)(6) 2022.The case was completed by changing the handpiece and the burr.After the case was completed, the handpiece was tested outside the sterile field by the nurse, and the handpiece heated and started to have a little bit of smoke.The part number and serial number of the handpiece is not available.
 
Manufacturer Narrative
The complaint is not confirmed.The reported device was not returned for investigation.No pictures were provided.However, per the event description is inferred that the cause for the reported failure is attributed to wear and tear: the c34 error is an indication of an overcurrent above 7.0a for 3 seconds.An overcurrent condition can be caused by a shaver handpiece motor that has reached end of life.The increased temperature on the shaver handpiece is also consistent with end of life.Per synergy and adapteur power system¿ ii (aps ii) shaver handpieces direction for use, dfu-0154-5 section f.Inspection and maintenance, the user is instructed to inspect the device for excessive heating, and the user is informed that the device may have reached end of life if critical errors or abnormal temperature are noticed.
 
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Brand Name
UNK
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key13995371
MDR Text Key298280854
Report Number1220246-2022-04707
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K932699
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 06/07/2023
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/16/2022
Initial Date FDA Received04/04/2022
Supplement Dates Manufacturer Received03/16/2022
Supplement Dates FDA Received06/07/2023
Is the Device Single Use? No
Type of Device Usage Initial
Patient Sequence Number1
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