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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. FIRSTPASS SUTURE PASSER

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ARTHROCARE CORP. FIRSTPASS SUTURE PASSER Back to Search Results
Model Number 22-4035
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/07/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference case-(b)(4).
 
Event Description
It was reported that during the set up before the surgery the top jaw of the firstpass suture was completely broke. No patient injuries or delay reported. Smith and nephew back-up device was available to complete the surgery.
 
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Brand NameFIRSTPASS SUTURE PASSER
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 Key11890433
MDR Text Key254309867
Report Number3006524618-2021-00664
Device Sequence Number1
Product Code HWQ
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number22-4035
Device Catalogue Number22-4035
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2021
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 Unkown

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