MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 60MMCORT; SCREW, FIXATION, BONE

Model Number	LO-PRO SCRW TM,SS 3.5X 60MMCORT
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/07/2019
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 via email that the facility submitted a medwatch report ((b)(4)) for the following incident: the patient is 47 years old and had a previous ankle fracture with syndesmotic fixation on (b)(6) 2019.Patient has elected to undergo hardware removal from the syndesmosis.Procedure: removal of one screw and screw head from the right lateral fibular plate.Description of operative procedure: the screw heads were identified with fluoroscopic imaging.The most distal screw was noted to have a broken screw head.The screw head was removed.The more proximal syndesmotic screw was then removed completely.Fluoroscopic evaluation of the ankle found the syndesmosis to be stable without medial clear space widening.Medwatch report provided noted that x-ray views of the right were taken on (b)(6) 2019.2 views of the right ankle show stable fixation without hardware failure at that point.Additional information obtained 7/22/2019: the facility has confirmed that the records indicate the reason for the second surgery was that the patient elected to undergo hardware removal from the syndesmosis.The broken screw head was discovered during the second surgery.The original and second surgeries were both performed by the same surgeon at the same facility.Additional information obtained 7/23/2019: the facility has confirmed that the actual arthrex part numbers were not recorded in the surgical log, the log just contained the product descriptions and the manufacturer (arthrex) name.Facility also reported that the only notation of any explants was as shown in the original reported information: "the most distal screw was noted to have a broken screw head.The screw head was removed.The more proximal syndesmotic screw was then removed completely." there was no mention in the surgical records of any other devices being explanted.Based on the product descriptions the following are believed to be the arthrex devices from the original (b)(6) 2019 procedure: ar-8963-04, guidewire trocar tip 1.35 x 130mm (qty 1), ar-8943br-06, plate distal fibula locking 6 hole right (qty 1), ar-8827l-22, screw locking 2.7 x 22 mm low profile (qty 1), ar-8827l-24, screw locking 2.7 x 24mm low profile (qty 2), ar-8835-55, screw low profile 3.5 x 55mm cortical (qty1), ar-8835-60, screw low profile 3.5 x 60mm cortical (qty 1), ar-8827l-20, screw locking 2.7 x 20mm (qty 2), ar-8835-14, screw cortical 3.5 x 14mm (qty 2), ar-8835-16, screw cortical 3.5 x 16 mm (qty 1), ar-8827-26, screw bone cortical nonlocking 2.7 x 26mm (qty 1).After review by an arthrex product manager it was determined that the most likely two screws mentioned as being explanted and partially explanted would be the ar-8835-55 and the ar-8835-60.Arthrex is unable to determine which of the two screws would have been the one that the screw head broke off of.

• Brand Name: LO-PRO SCRW TM,SS 3.5X 60MMCORT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8887213
• Report Number: 1220246-2019-01242
• Device Sequence Number: 3039276
• Product Code: HWC
• UDI-Device Identifier: 00888867047501
• UDI-Public: 00888867047501
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/13/2019

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 TM,SS 3.5X 60MMCORT
• Device Catalogue Number: AR-8835-60
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/13/2019
• 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: 106