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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. FIRSTPASS MINI STRAIGHT; ACCESSORIES,ARTHROSCOPIC

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ARTHROCARE CORP. FIRSTPASS MINI STRAIGHT; ACCESSORIES,ARTHROSCOPIC Back to Search Results
Model Number 72290128
Device Problems Break (1069); Separation Problem (4043)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that during use in an arthroscopy, the mouth of the firstpass mini broke off.It is unknown if there was a delay or if a backup device was available and how the issue was resolved.
 
Manufacturer Narrative
H10: internal complaint reference: (b)(4).
 
Event Description
It was reported that during use in an arthroscopy, the mouth of the firstpass mini broke off.All the broken pieces were removed from the patient with a grasper.A delay less or equal than 30 minutes were reported and the procedure was finished with a smith and nephew back up device.No patient injury or other complications were reported.
 
Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A clinical review states it was communicated via e-mail that the broken pieces were retrieved from the patient.The procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.The complaint was confirmed.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or misuse of the device.No containment or corrective actions are recommended at this time.
 
Manufacturer Narrative
Internal complaint reference: (b)(4).H10 h3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual evaluation showed the suture capture teeth are no longer in the upper jaw.A deformed suture capture was returned taped to the handle.There is bio debris in the jaw and on the insertion rod.A functional evaluation showed the jaws opened and closed as intended.The suture passer deployed as intended.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A clinical review states it was communicated via e-mail that the broken pieces were retrieved from the patient.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint was confirmed and the root cause was associated with unintended use of the device.Potential factors unrelated to the design or manufacture of the device that may lead to the failure reported include, but are not limited to: (1) excessive force (2) tissue thickness.No containment or corrective actions are recommended at this time.
 
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
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Brand Name
FIRSTPASS MINI STRAIGHT
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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12374373
MDR Text Key268364299
Report Number3006524618-2021-00877
Device Sequence Number1
Product Code NBH
UDI-Device Identifier00885556694558
UDI-Public00885556694558
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/30/2023
Device Model Number72290128
Device Catalogue Number72290128
Device Lot Number2063357
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/11/2021
Initial Date FDA Received08/26/2021
Supplement Dates Manufacturer Received10/07/2021
11/01/2021
07/24/2023
07/24/2023
Supplement Dates FDA Received10/08/2021
11/19/2021
07/26/2023
07/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/30/2020
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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