MAUDE Adverse Event Report: ARTHROCARE CORP. EVAC BENDING TOOL; INSTRUMENT, BENDING OR CONTOURING

Model Number E2020-01

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a tonsillectomy, the evac bending tool snapped off.Bender broke while bending wand before the physician started coblating.The piece did not fall into the patient.It broke on the mayo.The procedure was completed without surgical delay using a s+n back-up device.No further complications were reported.

Manufacturer Narrative

Internal complaint reference (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review found this case reports the evac bender wand broke before use in a tonsillectomy procedure.Per additional correspondence dated may 31, 2022, the ¿bender broke while bending wand before the physician started coblating.¿ reportedly, ¿the piece didn¿t fall into the patient.¿ ¿it broke on the mayo.¿ the surgeon reported that the bender and broken piece was in his possession.It was communicated, ¿the patient had a successful tonsillectomy and is doing well,¿ and the procedure was completed with no surgical delay using a backup device.Without the requested clinically relevant supporting documentation, the root cause of the reported ¿bender broke while bending wand¿ cannot be definitively concluded.The patient impact beyond the reported is not anticipated as the device reportedly broke outside of the patient before use and ¿the piece didn¿t fall into the patient.¿ it was communicated, that ¿the patient is doing.¿ therefore, no further clinical/medical assessment can be rendered.The complaint was not confirmed.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.

• Brand Name: EVAC BENDING TOOL
• Type of Device: INSTRUMENT, BENDING OR CONTOURING
• 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 Key: 14637679
• MDR Text Key: 293619205
• Report Number: 3006524618-2022-00281
• Device Sequence Number: 1
• Product Code: HXP
• UDI-Device Identifier: 00817470003567
• UDI-Public: 00817470003567
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E2020-01
• Device Catalogue Number: E2020-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention