MAUDE Adverse Event Report: ARTHROCARE CORP. SABER 30 DEGREE ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	AC4330-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the hip arthroscopy, it was required to perform a capsulotomy, a saber 30 degree icw was necessary, the device was passed to the surgical table and it was inserted into the patient's hip, the tip became entangled in the patient tissue, and when tried to remove it, the tip broke inside the patient.Broken piece was removed.Procedure was completed with the same device with no significant surgical delay or patient injury.
Additional Manufacturer Narrative
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.Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Factors not associated with the manufacture or design of the device which could result in damage to the tip could be using the wand as a lever to enlarge the surgical site or gain access to tissue.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SABER 30 DEGREE ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7540276
• Report Number: 3006524618-2018-00274
• Device Sequence Number: 19285898
• Product Code: GEI
• UDI-Device Identifier: 00817470004854
• UDI-Public: (01)00817470004854(17)201024(10)2007522
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K033584
• 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): 05/24/2018

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: Physician
• Device Expiration Date: 10/24/2020
• Device Model Number: AC4330-01
• Device Catalogue Number: AC4330-01
• Device Lot Number: 2007522
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR