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

Model Number 1200-01-1022

Device Problem Fracture (1260)

Patient Problems Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 03/20/2015

Event Type  Injury  

Manufacturer Narrative

The subject nail removal was completed with no issues, and the nail was sent to medshape for inspection.It is noted that the as-received condition of the nail may differ somewhat from the condition of the nail when removed from the patient, as the operating surgeon indicated that the edges of the broken nail "are a little flattened because we were bending the nail to clean it and look at the element" following removal.A photographic assessment of the nail and associated components was conducted.A device history record review was conducted on the subject lot.All requirements related to product manufacturing, assembly and packaging were met.No prior complaints or feedbacks were identified pertaining to the subject lot.The operating surgeon was contacted to obtain additional information related to the subject case as well as 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.Until firm bony union is achieved, the patient should employ adequate external support and restrict physical activities that would place stress upon the implant or allow movement at the site and delay healing.Therefore, it is important that immobilization of the site is maintained until firm bony union (confirmed by clinical and radiological examination) is established.Failure to immobilize the ankle during healing may result in bending and/or breakage of the device and/or failed fusion." the patient's non-compliance with post-surgical protocol in the form of playing handball as early as 6 weeks post-surgery could directly have contributed to nonunion and led to the nail outer body being overloaded, resulting in fracture.Additionally, section 5 of the package insert, "precautions," states "the dynanail ankle arthrodesis system should only be used by those physicians who have been trained in the appropriate, specialized procedures.Knowledge of appropriate surgical techniques, instrumentation, proper selection and placement of implants and postoperative patient care and management are essential to a successful outcome.For best results, always use the largest possible components and ensure that the components are properly positioned.Failure to do so may result in loosening, bending, cracking or fracture of the device or injury to the patient's bone or both." from the treating surgeon's correspondence, a new fellow was a co-surgeon on this case who "missed the nail with the drill bit on the tibia so our only compression was the nitinol," and it is noted that "manual compression steps were done wrong." further, section 6 of the package insert, "potential adverse effects," states that "adverse effects resulting from the use of the dynanail ankle arthrodesis system included "cracking or fracture of the implant components," and that such effects "may necessitate reoperation, revision or removal surgery." the subject surgeon stated that upon removal of the fractured nail, two screws were placed in the subtalar joint to treat the nonunion.Additionally, the subject surgeon indicated that the ankle joint experienced fusion despite the broken nail, and that there was additional bone formation in the subtalar joint over the course of treatment even though there was nonunion.Additionally, section 7 of the package insert, "patient selection information," lists that "the physician must determine if the device is appropriate for patients having any of the following physical or emotional conditions.Lacks an understanding that a metallic implant is not as strong as normal healthy bone and will bend, loosen, or fracture if excessive demand is placed on it." the patient's excessive physical loading of the implant during handball around six to eight weeks post-surgery suggest a lack of understanding by the patient.Finally, section 8 of the package insert, "patient counseling information," lists that "postoperative care and physical therapy should be structured to prevent loading of the operative extremity until stability is evident.Patients who are obese or noncompliant, as well as patients who could be predisposed to delayed union or nonunion must have auxiliary support." in the subject case, the patient was loading the operative extremity prior to stability being evident.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 failure, at this point in time, no further action is warranted, 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.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Medshape was notified by a surgeon user regarding a patient who experienced a fracture of a dynanail post-implantation.Per the surgeon, approximately six to eight weeks post-surgery, the patient began playing handball, causing him to experience pain and swelling.The patient returned to the clinic, where imaging revealed a fracture near the distal end of the nail.The surgeon removed the broken nail.

• Brand Name: DYNANAIL, 10 MM
• Type of Device: INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): MEDSHAPE, INC.; 1575 northside drive, nw; suite 440; atlanta GA 30318
• Manufacturer Contact: kenneth dupont ; 1575 northside drive, nw; suite 440; atlanta, GA 30318 ; 6782353336
• MDR Report Key: 5360220
• MDR Text Key: 35658770
• Report Number: 3007593722-2016-00001
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2017
• Device Model Number: 1200-01-1022
• Device Lot Number: 00623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2014
• 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: 31 YR