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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. SCORPION-MULTIFIRE NEEDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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ARTHREX, INC. SCORPION-MULTIFIRE NEEDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Back to Search Results
Model Number SCORPION-MULTIFIRE NEEDLE
Device Problems Difficult to Remove (1528); Component Missing (2306)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/26/2021
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
The procedure the patient underwent was an arthroscopic acromial decompression and mini open supraspinatus repair.The surgeon implanted 2 x 4.75 (ar_2324pslc) swivelocks, 1 loaded with fibertape and 1 with tigertape, these anchors formed the medial row for the tendon repair.The surgeon passed 2 tape limbs and 2 suture limbs, when he went to pass another suture with the scorpion, he noticed the tip of the needle was missing.The wound was then washed out with irrigation fluid.The needle tip which measured approximately 3mm (the multifire scorpion needle was measured against a new needle) was not retrieved during the wound wash out.The surgeon completed the rotator cuff supraspinatus repair passing the remaining tapes and sutures with a new scorpion multifire needle.Prior to finishing the surgery the surgeon checked the joint space for the needle tip which could not be seen.
 
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Brand Name
SCORPION-MULTIFIRE NEEDLE
Type of Device
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
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
vik bajnath
8009337001
MDR Report Key12335601
MDR Text Key268437251
Report Number1220246-2021-03527
Device Sequence Number1
Product Code MDM
UDI-Device Identifier00888867015951
UDI-Public00888867015951
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 08/18/2021
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
Device Operator Health Professional
Device Model NumberSCORPION-MULTIFIRE NEEDLE
Device Catalogue NumberAR-13995N
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/26/2021
Initial Date FDA Received08/18/2021
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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