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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 Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/25/2016
Event Type  malfunction  
Event Description
It was reported that the tip of the device broke off when the surgeon was pushing the instrument through tissue.Unable to confirm whether the broken piece was retrieved or left in situ.However, no patient injury or other complications have been reported.
 
Manufacturer Narrative
Additional/corrected: the returned accu-pass device was received with its needle broken near the distal end of the outer tube.Blue cobraid magnumwire was received captured by the needle.Needle and outer tube crimp was present.Per information provided, the tip of the accupass broke off when the surgeon was pushing the instrument through tissue.Based on our visual evaluation, the complaint was confirmed as the needle was received broken.An exact root cause could not be determined with confidence.A potential factor unrelated to the manufacture or design of the device that could have contributed to the reported event includes tissue thickness.Tissue thickness may affect suture placement including stitch depth and needle entry point.The instruction for use (ifu) were reviewed and 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 during manufacturing record review that would suggest the device did not meet product specifications upon release into distribution.
 
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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
jim gonzales
7000 w. william cannon
austin, TX 78735
5123585706
MDR Report Key6191217
MDR Text Key63233343
Report Number3006524618-2016-00347
Device Sequence Number1
Product Code NBH
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 company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 02/08/2017
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 Catalogue Number23-2005
Device Lot Number1153290
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/25/2016
Initial Date FDA Received12/20/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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