MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC FIBULINK REMOVAL KIT; WASHER, BOLT NUT

Model Number	FGS-1300
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Part # fgs-1300, lot # 21e008, supplier lot #: 21e008, release to warehouse date: 06 apr 2021, expiration date: 01 mar 2024, supplier: (b)(4), no ncr's generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and 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) 2021, the surgeon performed an open reduction internal fixation (orif) of bilmalleolar ankle fracture with syndesmotic injury.After using a synthes va lcp distal fibula plate to repair fibula fracture, and two cannulated screws to repair the medial malleolus.Surgeon then used a large tenaculum to reduce the syndesmosis injury and began preparing the bone for the fibulink following the surgical technique.Once the surgeon inserted the tibia screw to the correct depth the indicator groove was visible just lateral to the plate and a standard tensioning cap was used.The surgeon secured a clamp to the silver tube and pulled laterally and engaged the tensioning cap with the link by turning the clamp clockwise.The cap did engage the fibulink but would not tight to the degree that it maintained reduction of the syndesmosis injury.After attempting to tighten the tensioning cap for several minutes, while ensuring lateral tension on silver tube to prevent rotation i suggested that the surgeon pull back slightly on the tensioning knob.Once the surgeon pulled back on tensioning knob it disengaged from the tensioning cap.Unsuccessful attempts were made to reattach the tensioning knob to the cap.Following these attempts the surgeon decided he would like to remove the device completely.The fibula tensioning cap remover was used to successfully remove the cap.The link, suture and tibia screw remained in the patient.He used the fibula link and tibia screw remover and attempted to remove the link and tibia screw however the driver would not engage into the hexalobe of the tibia screw.The surgeon also used a tibia screw remover which did not work either.After many attempts to remove the link and tibia screw, the surgeon decided he would leave the device in patient as trying to remove it may cause unwanted damage.The surgeon then used a tight rope to complete this part of the procedure.The procedure was successfully completed with 30 minutes surgical delay reported.Patient satus is unknown.Concomitant devices reported: unknown va-lcp distal fibula plate (part# unknown, lot# unknown, quantity 1), unknown cannulated screws (part# unknown, lot# unknown, quantity unknown).This report is for one fibulink® syndesmosis repair kit/ss.This is report 2 of 2 for (b)(4).

• Brand Name: FIBULINK REMOVAL KIT
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12388091
• Report Number: 3013401747-2021-00057
• Device Sequence Number: 1232591
• Product Code: HTN
• UDI-Device Identifier: 00863176000324
• UDI-Public: 00863176000324
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K162805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2021

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 Expiration Date: 03/01/2024
• Device Model Number: FGS-1300
• Device Catalogue Number: FGS-1300
• Device Lot Number: 21E008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 10/01/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FIBULINK® REMOVAL KIT; FIBULINK® SYNDESMOSIS REPAIR KIT/SS.; UNK - PLATES: VA-LCP FIBULA.; UNK - SCREWS: CANNULATED.
• Patient Age: 67 YR