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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. SYNERGY RESECTION SHAVER CONSOLE; POWERED SURG ORTHOPEDIC INSTR

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ARTHREX, INC. SYNERGY RESECTION SHAVER CONSOLE; POWERED SURG ORTHOPEDIC INSTR Back to Search Results
Model Number SYNERGY RESECTION SHAVER CONSOLE
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/11/2023
Event Type  malfunction  
Event Description
On 7/11/2023, it was reported by a sales representative via sems that an ar-8305 synergy resection shaver console had an issue.The shaver handpiece was not recognized by the console.They tried 2 different handpieces with the same result.The patient was not affected by this.They switched out the console for a different one, and the case went on fine.This occurred during use in an unspecified procedure with no patient harm.Additional information was requested.
 
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.
 
Manufacturer Narrative
(hp board) this evaluation determined that the reported event occurred due to moisture intrusion on the hand piece board caused by normal wear and tear.Refer to (b)(4) for additional failure modes and information.
 
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Brand Name
SYNERGY RESECTION SHAVER CONSOLE
Type of Device
POWERED SURG ORTHOPEDIC INSTR
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
emily shafer
8009337001
MDR Report Key17489193
MDR Text Key320690015
Report Number1220246-2023-07465
Device Sequence Number1
Product Code HWE
UDI-Device Identifier00888867123854
UDI-Public00888867123854
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K932699
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 09/20/2023
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
Device Model NumberSYNERGY RESECTION SHAVER CONSOLE
Device Catalogue NumberAR-8305
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/11/2023
Initial Date FDA Received08/09/2023
Supplement Dates Manufacturer Received07/11/2023
Supplement Dates FDA Received09/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/22/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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