MAUDE Adverse Event Report: ARTHROCARE CORP. NEEDLE AND SUTURE CAPTURE; ACCESSORIES,ARTHROSCOPIC

Model Number	22-4036
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that during a shoulder arthroscopy the first pass implant failed and did not anchor to the clamp.The procedure was completed with a backup device and no significant delay or complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: b4: event description updated.
Event or Problem Description
It was reported that during a shoulder arthroscopy the first pass implant failed and did not anchor to the clamp, the suture was not being capture and it was impossible to handle the suture at ease and carry with the repair.The procedure was completed with a backup device and no significant delay or complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10: h3, h6: 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 the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10, h3, h6: the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection of what was returned revealed no manufacturing abnormalities.No visual issues were observed.The suture capture trap and loader were not returned with device.Needle and loader, needle unloader, and suture capture trap unloader were returned.A functional evaluation was not conduced as the suture capture trap and loader were not returned.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 an isolated event.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.

• Brand Name: NEEDLE AND SUTURE CAPTURE
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11097793
• Report Number: 3006524618-2020-01171
• Device Sequence Number: 14558481
• Product Code: NBH
• UDI-Device Identifier: 00817470000184
• UDI-Public: 00817470000184
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/14/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2022
• Device Model Number: 22-4036
• Device Catalogue Number: 22-4036
• Device Lot Number: 2040187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 01/19/2021; 01/29/2021; 05/13/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 01/26/2021; 02/04/2021; 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1