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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. DISP FIRSTPASS STR PASSR SELF PASSER

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ARTHROCARE CORP. DISP FIRSTPASS STR PASSR SELF PASSER Back to Search Results
Catalog Number 22-4038
Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Date 12/20/2017
Event Type  malfunction  
Manufacturer Narrative
The reported device was returned for evaluation and was intended for treatment. There was a relationship found between the returned device and the reported incident. The returned firstpass disposable device was received with the suture trap broken in half. No other visual discrepancies. Functional test cannot be perform due to the broken condition of the suture trap. Based on our visual evaluation the reported complaint "half of the self capturing trap door broke off" was confirmed and a root cause was unable to be determined with certainty. Factors unrelated to the manufacture or design of device that could have contributed to the reported event includes: excessive force can result in failure. Do not use this device as a lever for manipulating hard tissue or bone. Excessive force should not be applied to the device when manipulating soft tissue, bone, or hard objects. 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 device did not meet product specifications upon release into distribution. Not a foreign complaint as stated in the initial report.
 
Event Description
It was reported that the surgeon was passing ultratape through the subscap and half of the self capturing trap door broke off and fell in the shoulder. He searched for the piece arthroscopically and with mini c-arm for about 20-minutes. After looking around the piece is not in the shoulder joint and it must have migrated down the arm somewhere. Another firstpass was available to complete the repair.
 
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Brand NameDISP FIRSTPASS STR PASSR SELF
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 west william cannon drive
austin, TX 
MDR Report Key7152912
MDR Text Key247792201
Report Number3006524618-2017-00450
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
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/16/2020
Device Catalogue Number22-4038
Device Lot Number2006590
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 Received01/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/16/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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