MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLES KIT, FOR FIBERTAK SUTR ANCH; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	DISPOSABLES KIT, FOR FIBERTAK SUTR ANCH
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported on (b)(6) 2022 by a facility representative via sems that an ar-3600dc flexible drill broke at the laser mark.This was discovered during a case and broke during use.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection it was noted that the flexible drill had broken.Overall length was unable to be measured due to the broken state of the device.Diameter was measure and found to be within tolerance per drawing specifications.The cause of this remains undetermined.

• Brand Name: DISPOSABLES KIT, FOR FIBERTAK SUTR ANCH
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14195885
• Report Number: 1220246-2022-04813
• Device Sequence Number: 5245930
• Product Code: HWE
• UDI-Device Identifier: 00888867101951
• UDI-Public: 00888867101951
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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 Model Number: DISPOSABLES KIT, FOR FIBERTAK SUTR ANCH
• Device Catalogue Number: AR-3600DC
• Device Lot Number: 14697050
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2022
• Supplement Date Received by Manufacturer: 04/09/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown