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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. GRAFTPRO, GRAFT PREP BOARD; ORTHOPEDIC MANUAL SURG INSTR

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ARTHREX, INC. GRAFTPRO, GRAFT PREP BOARD; ORTHOPEDIC MANUAL SURG INSTR Back to Search Results
Model Number GRAFTPRO, GRAFT PREP BOARD
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/17/2023
Event Type  malfunction  
Event Description
On (b)(6) 2023, it was reported by a distributor via sems-06059959 that an ar-2950d graft prep board had missing screws.It was stated that the screw was found and had no effect on the patient during surgery.This was discovered during an unspecified procedure, with no patient harm.
 
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.
 
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Brand Name
GRAFTPRO, GRAFT PREP BOARD
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 Key18139122
MDR Text Key328148914
Report Number1220246-2023-08745
Device Sequence Number1
Product Code LXH
UDI-Device Identifier00888867221505
UDI-Public00888867221505
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 11/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGRAFTPRO, GRAFT PREP BOARD
Device Catalogue NumberAR-2950D
Device Lot Number43212052
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/17/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/09/2021
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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