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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. 24MM PRIMARY REAMER; ORTHOPEDIC MANUAL SURG INSTR

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ARTHREX, INC. 24MM PRIMARY REAMER; ORTHOPEDIC MANUAL SURG INSTR Back to Search Results
Model Number 24MM PRIMARY REAMER
Device Problem Dull, Blunt (2407)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/30/2023
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 10/30/2023, it was reported by a sales representative via (b)(4)that an ar-9618-24 24mm primary reamer and an ar-9619-36 36mm peripheral reamer did not ream and may be dull or broken.This was discovered during an unspecified procedure with no reported patient harm.
 
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Brand Name
24MM PRIMARY REAMER
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 Key18220638
MDR Text Key330558950
Report Number1220246-2023-08939
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 11/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24MM PRIMARY REAMER
Device Catalogue NumberAR-9618-24
Device Lot Number022121
Was Device Available for Evaluation? No
Date Manufacturer Received10/30/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/30/2021
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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