MAUDE Adverse Event Report: MEDSHAPE, INC. DYNANAIL TTC FUSION NAIL, 10MM; INTRAMEDULLARY FIXATION ROD

Model Number 1200-01-1022

Device Problem Fracture (1260)

Patient Problems Pain (1994); Joint Swelling (2356); Missing Value Reason (3192)

Event Date 03/07/2016

Event Type  Injury  

Manufacturer Narrative

The subject nail was unavailable for review, as it remains in the patient.A review of the medical records, including post operative x-rays, indicates the device was used in combination with a 3d printed truss implant (talus replacement).The truss also appears to have failed union with the calcaneus and tibia, and may have shifted posteriorly post-operatively and come into contact with the subject nail at the tibial interface.A device history record review was conducted on this lot, 00622.All requirements related to product manufacturing, assembly and packaging were met.No prior complaints or feedbacks were identified pertaining to lot 00622.Both the operating and post operative followup surgeons were contacted to obtain additional information related to the subject case.The operating surgeon had retired from practice prior to the reported follow-up, and only the follow-up imaging was available to create a case / incident timeline, with the associated patient imaging.There is a warning in the package insert that infers this type of event can occur: section 4, "warnings," includes the following statement: "the dynanail ankle arthrodesis nail is intended to facilitate healing but is not designed to support the patient's body weight in the presence of a delayed union or nonunion of bone." the patient complained of swelling and pain at the ankle joint approximately 7 months post operatively, suggesting that a delayed union or nonunion may have occured, contributing to the failure.The patient indicated that their maximum activity post operative was limited to walking up and down stairs, suggesting that excessive loading from strenuous activity was not occuring.Further, section 6 of the package insert, "potential adverse effects," states that "adverse effects resulting from the use of the dynanail ankle arthrodesis system include cracking or fracture of the implant components," and that such effects "may necessitate reoperation, revision or removal surgery." at this time, the subject nail remains in the patient and the follow-up surgeon has prescribed a metal brace to minimize ankle motion in an effort to further facilitate fusion with the truss implant and to mitigate the potential for revision surgery.Based on the information provided, the exact root cause of the incident could not be determined.Based on the overall extremely low complaint rate for this type of failure, and in light of the use of the truss implant as a talus replacement, no further action is warranted at this time and corrective action is not indicated.However, medshape will continue to track any related complaints within this device family as means of monitoring the extent with which this complaint is observed in the field.In addition, should additional information be received, including removal and return of the implant for further evaluation, the investigation will be re-opened as necessary.Device not returned to manufacturer.

Event Description

Medshape was contacted by the patient on september 6, 2016.The patient indicated that they had received a dynanail ttc fusion implant on (b)(6) 2015, and began experiencing swelling and pain in (b)(6) 2016.A post-operative follow-up showed a possible nail fracture near the distal end.The nail remains in the patient, who continues to wear a metal brace.

• Brand Name: DYNANAIL TTC FUSION NAIL, 10MM
• Type of Device: INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): MEDSHAPE, INC.; 1575 northside drive nw; suite 440; atlanta GA 30318
• Manufacturer Contact: jack griffis ; 1575 northside drive nw; suite 440; atlanta, GA 30318 ; 6782353311
• MDR Report Key: 6004113
• MDR Text Key: 56596676
• Report Number: 3007593722-2016-00002
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: M970120001102202
• UDI-Public: M970120001102202
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2017
• Device Model Number: 1200-01-1022
• Device Lot Number: 00622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2014
• 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
• Treatment: 4WEB MEDICAL TRUSS
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 54