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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 08/16/2023
Event Type  malfunction  
Manufacturer Narrative
Additional information: h6 (use error) the reported event of "an ar-8305 console is showing an error message once the footswitch is connected" was confirmed.This evaluation determined that the reported event occurred due to moisture intrusion resulting from use error.
 
Event Description
On 08/16/2023, it was reported by a sales representative via sems that an ar-8305 console is showing an error message once the footswitch is connected.This was discovered during a procedure with no patient harm.
 
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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 Key17737054
MDR Text Key323284999
Report Number1220246-2023-07870
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
Report Date 09/13/2023
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
Device Lot Number10210943
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/16/2023
Initial Date FDA Received09/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2018
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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