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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. ACCU-PASS DIRECT CRESCENT XL PASSER

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ARTHROCARE CORP. ACCU-PASS DIRECT CRESCENT XL PASSER Back to Search Results
Catalog Number 23-2005
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2017
Event Type  malfunction  
Manufacturer Narrative
There was a relationship found between the returned device and the reported event. Visual inspection for the device revealed the needle crescent broke off. No other visual discrepancies were found. Functional evaluation was not performed due to the broken condition of the returned device. Per information provided by the customer, the tip broke while passing through the tissue. Based on our visual investigation the reported event was confirmed; however, the root cause cannot be determined with confident. Factors unrelated to the manufacturing or design of the device that could have contributed to the reported event includes: as with any surgical instrument, careful attention should be made to assure that excessive force is not placed on this instrument. Excessive force can result in failure. Tissue thickness may affect suture placement including stitch depth and needle entry point. The instruction for use (ifu) was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality. There were no indications that would suggest that the devices did not meet product specifications upon release into distribution. Device returned for evaluation. Device evaluated by the manufacturer.
 
Event Description
It was reported that the tip broke on two devices (from the same lot) while passing through the tissue. The broken pieces were removed and the procedure was completed with a back-up device without further complications. Complaint 1 of 2. See (b)(4) for 2nd device.
 
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Brand NameACCU-PASS DIRECT CRESCENT XL
Type of DevicePASSER
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
jim gonzales
7000 w. william cannon
austin, TX 78735
MDR Report Key7038708
MDR Text Key255091334
Report Number3006524618-2017-00367
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number23-2005
Device Lot Number1174558
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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