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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC.; ORTHOPEDIC MANUAL SURG INSTR
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ARTHREX, INC.; ORTHOPEDIC MANUAL SURG INSTR Back to Search Results
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Date 11/10/2023
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 11/10/2023, a sales representative reported via (b)(4) that the surgeon used the 5566vip arthrex vip web portal to plan the procedure.The post-operation images show that the pin and the implant are angled more superiorly than the normal and have an inferior tilt.The surgeon has expressed displacement with the procedural outcome.Additional information requested.
 
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Brand Name
UNK
Type of Device
ORTHOPEDIC MANUAL SURG 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 Key18284116
MDR Text Key329954461
Report Number1220246-2023-09260
Device Sequence Number1
Product Code LXH
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 Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 12/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received11/10/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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