MAUDE Adverse Event Report: ARTHREX, INC. CANN SCRW,3.75X 36MM PT THRDED; SCREW, FIXATION, BONE

Model Number	CANN SCRW,3.75X 36MM PT THRDED
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/23/2020
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 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 during an (b)(6) 2020 latarjet procedure on revision case with bone loss, the surgeon sized, shaped, and drilled two 1.6 k wires into the coracoid graft.Using the 2.75 cannulated drill, tunnels were drilled to the appropriate depths for each 3.75mm fully threaded screw.The first screw was placed over the k wire and drilled with power down to about 5 millimeters shy of compression.A hand screwdriver was then used to tighten the screw.After 3 turns, the head sheared off and left about 4 millimeters of screw shaft protruding from the coracoid graft with zero compression.The screw head was able to be removed from the k wire and out of the patient.The surgeon inserted the 2nd screw by drilling to a similar depth, slightly shy of any compression.The hand screwdriver was used and adequate compression was provided for screw number two.A pair of needle-nosed pliers was opened to try and remove the first screw¿s shaft from the glenoid.The attempt was unsuccessful.The remnants of the screw head and fragments were discarded by the scrub tech on the back table.The patient was assessed and the shoulder did not dislocate or have much translation.The surgeon considered revising the entire construct, but chose not to in order to prevent damaging the head of the screw providing compression.The date of the patient's original anterior bankart instability procedure is unknown.The revision was being performed due to degenerative/anterior inferior bone loss which resulted in instability and dislocation.It was reported that the revision was not due to any issues with the original arthrex implants and no original arthrex implants were explanted during the revision.

• Brand Name: CANN SCRW,3.75X 36MM PT THRDED
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11004109
• Report Number: 1220246-2020-02410
• Device Sequence Number: 11715780
• Product Code: HWC
• UDI-Device Identifier: 00888867041073
• UDI-Public: 00888867041073
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• 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
• Report Date (Section B): 12/14/2020

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: CANN SCRW,3.75X 36MM PT THRDED
• Device Catalogue Number: AR-7000-36
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 12/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other