MAUDE Adverse Event Report: ARTHREX, INC. DISP INSTR. KIT FOR TENO SCRW; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	DISP INSTR. KIT FOR TENO SCRW
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
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 device disposition is unknown.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was discovered during maude review (report key (b)(4)) that the facility had submitted a medwatch report (b)(4) (which has also been received by arthrex).Facility reported the following: ¿the thread provided by the kit to whipstitch the tendon was short.Another one was supplied and used to pass through the metal loop at the end of the driver.The metal loop was broken when the screw was inserted.A second screw was done with the same outcome.The tendon was not driven in.¿ upon investigation the sales rep, who was present during the procedure, has provided the following information: sales rep states he had expressed that the surgeon needed to size to make sure the tendon was not larger than the 3.5mm hole that was drilled.The surgeon chose to not size the tendon prior to drilling the 3/5mm hole.The surgeon proceeded to try to plug the tendon into the hole with a tenodesis driver and the suture broke at this time.Rep further states that the tendon length was too short to advance in the bone and tendon length was also larger than the size drill surgeon chose to use which may have led to the suture breaking while forcing the tendon into the bone.Rep also indicated that surgeon loaded both limbs of suture in the passing wire with too much length and used excess force that may have caused the wire loop from the ar-1676ds to break during suture transfer.To complete the procedure the surgeon proceeded to do a soft tissue tenodesis where surgeon tied the fdl to the fhl for tenodesis.

• Brand Name: DISP INSTR. KIT FOR TENO SCRW
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8484020
• Report Number: 1220246-2019-01010
• Device Sequence Number: 2015090
• Product Code: GAT
• UDI-Device Identifier: 00888867020801
• UDI-Public: 00888867020801
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K041553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/04/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: DISP INSTR. KIT FOR TENO SCRW
• Device Catalogue Number: AR-1676DS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other