MAUDE Adverse Event Report: ARTHREX, INC. LOCKING SCREW, TITANIUM 3.5MM X 20MM; SCREW, FIXATION, BONE

Model Number	LOCKING SCREW, TITANIUM 3.5MM X 20MM
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/08/2018
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 cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
During removal of screws/hardware post lisfranc healing - screws were broken.The devices involved were as follows: ar-8935l-26 qty 1.Ar-8935l-20 qty2.Ar-8935-18 qty 1.Additional information obtained 8/27/18: the original lisfranc procedure took place on (b)(6) 2017.It was discovered that the screws were broken and the revision was scheduled due to patient pain and broken hardware.The date of the revision procedure was (b)(6) 2018, during which broken screws were explanted.Both original and revision procedures were performed at the same facility by the same surgeon.It is unknown if all original implants were explanted during the revision.Risk manager could only confirm that the reported screws were explanted.

• Brand Name: LOCKING SCREW, TITANIUM 3.5MM X 20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7846930
• Report Number: 1220246-2018-00627
• Device Sequence Number: 1939747
• Product Code: HWC
• UDI-Device Identifier: 00888867050914
• UDI-Public: 00888867050914
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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: LOCKING SCREW, TITANIUM 3.5MM X 20MM
• Device Catalogue Number: AR-8935L-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/05/2018
• 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
• Patient Weight: 62