MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM; NAIL,FIXATION,BONE

Model Number	212.104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.Additional product code: ktt.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an ankle revision on (b)(6) 2018, due to a broken krschner wire (k-wire) in medial malleolus and instability.The hardware was originally placed on (b)(6) 2017.During the revision, the surgeon removed one (1) unknown 4.0 cancellous screw and the broken k-wire from the medial malleolus.All k-wire fragments were removed without any additional medical intervention being required.The 4.0 mm cancellous screw was replaced with a 3.5 mm syndesmosis cortical screw to make the construct more stable.A second screw; a 3.5 mm locking screw that was previously implanted through a plate on the fibula was replaced through the medial malleolus with a longer syndesmosis cortex screw as the surgeon had not addressed the syndesmosis in the original surgery and the construct was unstable.There was reportedly no consequence to the patient, the patient had no additional clinical findings and no known comorbidities.The patient was reported to be stable at the end of the procedure.Concomitant devices reported: locking plate: (part number unknown, lot number unknown, quantity 1).This report is for one (1) 3.5 mm locking screw 16 mm.This is report 1 of 3 for (b)(4).

• Brand Name: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7356928
• Report Number: 2939274-2018-51133
• Device Sequence Number: 10907913
• Product Code: JDS
• UDI-Device Identifier: 10886982151780
• UDI-Public: (01)10886982151780(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2018

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: 212.104
• Device Catalogue Number: 212.104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 03/21/2018
• 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: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 84