MAUDE Adverse Event Report: ARTHREX, INC. REUSABLE SUTURE TENSIONER; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	REUSABLE SUTURE TENSIONER
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
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.
Event or Problem Description
It was reported that the ar-7297-st broke at the connection when the surgeon was tensioning.Nothing went into the patient and the total shoulder case was completed.
Additional Manufacturer Narrative
Complaint confirmed, the tip shaft subassembly was found to be broken.The cause is undetermined, however a likely cause of the event is excessive tension in the subassembly due to the tip shaft subassembly being jammed or prevented from moving while the screw shaft subassembly is backing out / unscrewed.

• Brand Name: REUSABLE SUTURE TENSIONER
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11398171
• Report Number: 1220246-2021-02653
• Device Sequence Number: 17025063
• Product Code: GAT
• UDI-Device Identifier: 00888867289093
• UDI-Public: 00888867289093
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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 Model Number: REUSABLE SUTURE TENSIONER
• Device Catalogue Number: AR-7297-ST
• Device Lot Number: 051922
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 03/02/2021
• Patient Sequence Number: 1