MAUDE Adverse Event Report: ARTHREX, INC. LOCKING SCREW, TITANIUM 3.5MM X 24MM; SCREW, FIXATION, BONE

Model Number	LOCKING SCREW, TITANIUM 3.5MM X 24MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a procedure, when the surgeon was putting in an ar-8935l-24 in the patient, the top thread of the screw broke off.The titanium thread went through the surgeons gloves but did not puncture his skin.The surgeon was able to remove the screw and put in a different one for final fixation, and no pieces were left behind in the patient.

• Brand Name: LOCKING SCREW, TITANIUM 3.5MM X 24MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12032447
• Report Number: 1220246-2021-03297
• Device Sequence Number: 3800385
• Product Code: HWC
• UDI-Device Identifier: 00888867050952
• UDI-Public: 00888867050952
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/21/2021

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: LOCKING SCREW, TITANIUM 3.5MM X 24MM
• Device Catalogue Number: AR-8935L-24
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1