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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2020

Event Type  Injury  

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 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
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 10218064
• MDR Text Key: 197210778
• Report Number: 1220246-2020-01940
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867050426
• UDI-Public: 00888867050426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: LO-PRO SCRW,TI,3.5MMX 16MM
• Device Catalogue Number: AR-8935-16
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other