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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. ACCU-PASS DIRECT CRESCENT XL; ACCESSORIES,ARTHROSCOPIC

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ARTHROCARE CORP. ACCU-PASS DIRECT CRESCENT XL; ACCESSORIES,ARTHROSCOPIC Back to Search Results
Catalog Number 23-2005
Device Problem Separation Problem (4043)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/05/2022
Event Type  Injury  
Event Description
It was reported that during an arthroscopy procedure, the surgeon passed the accupass direct crescent xl through the labrum and when he removed the device from the labrum having passed the suture, it was observed that the tip of the hook was missing; tip was removed from patient by suction.The procedure was completed with a back-up device and a delay greater than 30 minutes was reported.No patient complications were reported.
 
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection of the returned instrument shows no manufacturing abnormalities.The tip of the hook is detached.Product was out of the original packaging.No packaging returned.A functional evaluation could not be conducted due to hook being broken.It was determined the device contributed to the reported event.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include: (1) excessive force.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No containment or corrective actions are recommended at this time.Our clinical investigation concluded: a clinical review states per case details, the broken tip was retrieved from the patient.The procedure was completed using a back-up device.The procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Per e-mail communication, the patient status was reported as ¿ok.¿ since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.
 
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Brand Name
ACCU-PASS DIRECT CRESCENT XL
Type of Device
ACCESSORIES,ARTHROSCOPIC
Manufacturer (Section D)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
Manufacturer (Section G)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key13342400
MDR Text Key284362095
Report Number3006524618-2022-00029
Device Sequence Number1
Product Code NBH
UDI-Device Identifier00885556724569
UDI-Public885556724569
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number23-2005
Device Lot Number2076824
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/05/2022
Initial Date FDA Received01/25/2022
Supplement Dates Manufacturer Received04/18/2022
Supplement Dates FDA Received05/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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