MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SMOOTH WIRE/1.8MM DIAMETER 400MM LONG; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	03.311.032
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on (b)(6) 2020, the patient underwent an unknown procedure.During the procedure, a tensioner had an unknown allegation.It is unknown if there was any surgical delay.The procedure outcome and patient status are unknown.This complaint involves 1 device.This report is for 1 smooth wire/1.8mm diameter 400mm long this is report 1 of 1 for (b)(4).
Event or Problem Description
It was reported on (b)(6) 2020, the patient underwent a do ring fixator application for sharcots foot (r), distal tibia procedure.During tensioning of the smooth wire the tensioner came apart resulting in the smooth wire being stuck in the tensioner.The wire had to be cut in order to remove the tensioning device.A back-up tensioner was used and the surgery continued.There was an approximately five (5) minute surgical delay.The procedure was completed successfully.The patient reportedly had no issues.

• Brand Name: SMOOTH WIRE/1.8MM DIAMETER 400MM LONG
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10994640
• Report Number: 2939274-2020-05561
• Device Sequence Number: 10960346
• Product Code: KTT
• UDI-Device Identifier: 10886982077974
• UDI-Public: (01)10886982077974
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K092190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.311.032
• Device Catalogue Number: 03.311.032
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/12/2020
• Supplement Report FDA Received Date: 01/06/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TENSIONER
• Patient Age: 48 YR
• Patient Weight: 99