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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
Model Number 22-4038
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that during rotator cuff repair procedure the firstpass suture passer's retrieval jaw was not working correctly, when the instrument was reviewed it was noticed the top jaw snapped and half was no longer there. The broken piece was removed from the patient. The procedure had a delay of under 30 min and it was completed using another firstpass suture passer. No injury to the patient was reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key9903835
MDR Text Key185739350
Report Number3006524618-2020-00139
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
EXEMPT.
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/01/2022
Device Model Number22-4038
Device Catalogue Number22-4038
Device Lot Number2040225
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2019
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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