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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, DUAL SPIKE PUNCH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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ARTHREX, INC. IBALANCE TKA, DUAL SPIKE PUNCH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number IBALANCE TKA, DUAL SPIKE PUNCH
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 04/29/2021
Type of Reportable Event Malfunction
Additional 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 or Problem Description
It was reported that the ar-613-65 broke during insertion during a tka procedure.The rep reported the device did not break into discrete pieces.The case was completed successfully by using another tray.
 
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Brand Name
IBALANCE TKA, DUAL SPIKE PUNCH
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11841215
Report Number1220246-2021-03083
Device Sequence Number4490926
Product Code LXH
UDI-Device Identifier00888867116733
UDI-Public00888867116733
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 05/18/2021
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
Operator of Device Health Professional
Device Model NumberIBALANCE TKA, DUAL SPIKE PUNCH
Device Catalogue NumberAR-613-65
Device Lot Number04511738
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/29/2021
Initial Report FDA Received Date05/18/2021
Patient Sequence Number1
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