MAUDE Adverse Event Report: ARTHREX, INC. QCKFIX SCRW,TI CANN ST,CANC.,4.0X 40MM; SCREW, FIXATION, BONE

Model Number	QCKFIX SCRW,TI CANN ST,CANC.,4.0X 40MM
Health Effect - Clinical Codes	Pain (1994); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/11/2020
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 the surgeon was performing a second surgery to remove hardware that had been implanted (b)(6) 2018.The second surgery was taking place due to painful hardware.When the surgeon tried to remove three screws from the patient the head broke off of each of the screws.The bodies of the screws were left in the patient.The heads that broke off of the screws were removed from the patient.The surgeon was using a screw driver by hand for the removal.The screw part numbers are: ar-8740-38pts, ar-8740-40pts, ar-8740-42pts.The body of the screws were left in the patient and only the heads of the screws, which broke off, were explanted.The heads of the screws are not available to return for evaluation.

• Brand Name: QCKFIX SCRW,TI CANN ST,CANC.,4.0X 40MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10631144
• Report Number: 1220246-2020-02209
• Device Sequence Number: 19596605
• Product Code: HWC
• UDI-Device Identifier: 00888867046443
• UDI-Public: 00888867046443
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/05/2020

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: QCKFIX SCRW,TI CANN ST,CANC.,4.0X 40MM
• Device Catalogue Number: AR-8740-40PTS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/05/2020
• 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