MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS TIGHTROPE SYN- DESMOSIS REPAIR KIT, SS; WASHER, BOLT NUT

Catalog Number AR-8926SS

Device Problems Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/15/2015

Event Type  Injury  

Event Description

It was reported that during an ankle fracture repair, the button slid through the fibula and did not stay on location.The surgeon was not able to retrieve it.A new hole was drilled on a different location with a new tight rope to complete the case.Follow-up investigation: when surgeon drilled the guide through the fibula and tibia he did not have it in the proper location in the center of the bone.When inserting the tightrope the button went through the bone.X-ray was taken and button was located between the fibula and tibia and surgeon chose not to attempt to remove the button from this location.Surgeon drilled in a new location and used another tightrope to complete the case.

Manufacturer Narrative

Patient demographics (date of birth, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.The device was requested/is expected but has not yet been received.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.A most likely cause of the event is as stated in the description that the surgeon drilled the guide through the fibula and tibia and he did not have it in the proper location in the center of the bone.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.Device expected but not yet returned.

• Brand Name: KNOTLESS TIGHTROPE SYN- DESMOSIS REPAIR KIT, SS
• Type of Device: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 4835913
• MDR Text Key: 5932033
• Report Number: 1220246-2015-00147
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Catalogue Number: AR-8926SS
• Device Lot Number: 12914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR