MAUDE Adverse Event Report: ARTHROCARE CORP. PERC DC; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	SDC01-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Injury (2348); Intraoperative Pain (2662)
Date of Event	06/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a coldplasma neocloplasty of civ-cv, cvi-cvii, cvii-thi discs the perc dc spine tip of the wand has broken off it remains inside the patient vertebral body in the civ-cv segment level.It is unknown if there was an available back up device or a significant delay during the procedure.In the postoperative period, the existing neurological deficit regressed significantly, the vertebrogenous pain syndrome and paravertebral muscle tension persist.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h6 the device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.Without the requested relevant clinical information, operative report, radiographs, or the wand, the root cause of the tip breakage cannot be determined.We cannot rule out the possibility of pain, mri restrictions, and micro-motion/migration of the retained wand tip.It is unknown if there was a backup device or significant delay to the procedure.There were no reported recommendations or planned intervention at this time.Procedural variance cannot be ruled out as a cause of the failure as it cannot be concluded if the device failed.Should additional medical information be provide, this complaint will be re-assessed.No further clinical/medical assessment is warranted at this time.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.There are no indications to suggest the device did not meet product specifications upon release into distribution.

• Brand Name: PERC DC
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10262205
• Report Number: 3006524618-2020-00473
• Device Sequence Number: 3004646
• Product Code: GEI
• UDI-Device Identifier: 00817470006162
• UDI-Public: 00817470006162
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2022
• Device Model Number: SDC01-01
• Device Catalogue Number: SDC01-01
• Device Lot Number: 2039122
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 07/12/2020
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention