MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW; SCREW, FIXATION, BONE

Model Number	SUTR ANCH,CRKSCRW
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
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 that during an achilles tendon refixation surgery the anchor broke off while screwing in.The broken pieces were retrieved from patient.No harm for patient, operator or third party was reported.The treatment was finished successfully with a new device from a different manufacturer.It was not necessary to do a second treatment.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual evaluation, it was noted that the screw is broken, the hex of the screw is inside the distal end of the driver.However, the broken piece was not returned for investigation.It probably causes of this event can be the excessive force applied during use or the bone hardness.The cause remains undetermined.

• Brand Name: SUTR ANCH,CRKSCRW
• Common Device Name: SCREW, FIXATION, BONE
• 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: 15842695
• Report Number: 1220246-2022-05792
• Device Sequence Number: 17586340
• Product Code: HWC
• UDI-Device Identifier: 00888867022683
• UDI-Public: 00888867022683
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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: 07/31/2025
• Device Model Number: SUTR ANCH,CRKSCRW
• Device Catalogue Number: AR-1915SNF-1
• Device Lot Number: 11562098
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown