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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC.; MANUAL INSTR, GENERAL SURGICAL
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ARTHREX, INC.; MANUAL INSTR, GENERAL SURGICAL Back to Search Results
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2023
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 (b)(6) 2023, it was reported by a sales representative via sems (b)(4) that an ar-12990 knee scorpion needle broke off inside the cannulation of the knee scorpion suture passer.The portion that broke off is lodged in the device and no pieces broke off inside the patient.The case was completed successfully by opening another knee scorpion and needle to complete the case.This was discovered during an meniscal root repair procedure on 10/20/23, with no reported patient harm.
 
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Brand Name
UNK
Type of Device
MANUAL INSTR, GENERAL SURGICAL
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 Key18180623
MDR Text Key328619561
Report Number1220246-2023-08828
Device Sequence Number1
Product Code MDM
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 11/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/24/2023
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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