MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.0MMX 20MMCORT; SCREW, FIXATION, BONE

Model Number LO-PRO SCRW,TI,3.0MMX 20MMCORT

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/12/2020

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 an ankle procedure, during insertion of the ar-8933-20, lo-profile screw the head of the screw broke off.The body of the screw was left in the patient and is flush with the fibula.The broken piece was removed.The surgeon drilled a second insertion site and the case was completed using a different ar-8933-20, lo-profile screw.

• Brand Name: LO-PRO SCRW,TI,3.0MMX 20MMCORT
• 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: 10213506
• MDR Text Key: 197024671
• Report Number: 1220246-2020-01929
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867049567
• UDI-Public: 00888867049567
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• 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,3.0MMX 20MMCORT
• Device Catalogue Number: AR-8933-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2020
• 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