MAUDE Adverse Event Report: ARTHROCARE CORP. ACCU-PASS DIRECT CRESCENT XL; ACCESSORIES,ARTHROSCOPIC

Catalog Number	23-2005
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during arthroscopy procedure, outside the patient, the accu-pass direct crescent xl tip is chipped but still on.The procedure was finished with a smith and nephew backup device.Surgical delay less than or equal to 30 mins.Patient injuries were not reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection of the returned instrument shows no manufacturing abnormalities.The tip of the device is detached.A functional evaluation could not be conducted due to detached tip.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 confirmed.Factor(s) that could have contributed to the reported event include: (1) excessive force.No containment or corrective actions are recommended at this time.

• Brand Name: ACCU-PASS DIRECT CRESCENT XL
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11580376
• Report Number: 3006524618-2021-00397
• Device Sequence Number: 20045089
• Product Code: NBH
• UDI-Device Identifier: 00885556724569
• UDI-Public: 885556724569
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 06/01/2021

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: 08/07/2023
• Device Catalogue Number: 23-2005
• Device Lot Number: 2058254
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 03/28/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1