MAUDE Adverse Event Report: MEDSHAPE, INC. DYNANAIL, 10 X 220 MM; INTRAMEDULLARY FIXATION ROD

Model Number	1200-01-1022
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The nail implantation was completed by dr.(b)(6), (b)(6) 2018 and the nail removal was completed by dr.(b)(6), (b)(6) 2019.After removal, the nail and nail components were sent to medshape for inspection / evaluation (06/2019).It is noted that the as-received condition of the nail may differ from the condition of the nail when removed from the patient.A photographic assessment of the nail and associated components was conducted.A device history record 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.Both surgeons were contacted to obtain additional information and patient imaging related to the subject case, but no information was received.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." further, section 6 of the package insert, "potential adverse effects," states that "adverse effects resulting from the use of the dynanail ankle arthodesis system include[?] cracking or fracture of the implant components," and that such effects "may necessitate reoperation, revision or removal 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 failure, at this point in time, no further action is warranted, and corrective action is not indicated.Medshape will continue to track any related complaints within this device family, including previous similar mdrs, 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 re-opened as necessary.
Event or Problem Description
Medshape was notified regarding a patient who experienced a fracture of a dynanail post-implantation.

• Brand Name: DYNANAIL, 10 X 220 MM
• Common Device Name: INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): MEDSHAPE, INC.; 1575 northside dr nw; suite 440; atlanta GA 30318
• MDR Report Key: 8804379
• Report Number: 3007593722-2019-00001
• Device Sequence Number: 13538896
• Product Code: HSB
• UDI-Device Identifier: M97012000110220
• UDI-Public: M97012000110220
• Combination Product (Y/N): N
• PMA/510(K) Number: K113828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 02/28/2021
• Device Model Number: 1200-01-1022
• Device Lot Number: 02272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR