MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 16MM; SCREW, FIXATION, BONE

Model Number	LO-PRO SCRW,TI,3.5MMX 16MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2020
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 a distal radius orif procedure, upon final insertion of the ar-8935-16 (3.5 low profile screw), the head of the screw broke off of the screw body.All of the screw body remained in the patient (approximately 16 mm).This occurred during the final seating of the screw.The surgeon used and ar-8916-14, 1.7mm drill bit to prep the bone socket.The patient was reported to have good bone quality.Patient was a (b)(6) male.After the screw head broke off and the screw body remained, it was reported that the two other distal 3.5 cortical screws had good purchase and the surgeon was confident enough in the construct to proceed with the case.The case was completed.

• Brand Name: LO-PRO SCRW,TI,3.5MMX 16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10218064
• Report Number: 1220246-2020-01940
• Device Sequence Number: 2404221
• Product Code: HWC
• UDI-Device Identifier: 00888867050426
• UDI-Public: 00888867050426
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2020

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: LO-PRO SCRW,TI,3.5MMX 16MM
• Device Catalogue Number: AR-8935-16
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/01/2020
• 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