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U.S. Department of Health and Human Services

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

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MEDSHAPE, INC. DYNANAIL, 10 X 220 MM INTRAMEDULLARY FIXATION ROD Back to Search Results
Model Number 1200-01-1022
Device Problem Fracture (1260)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 03/15/2019
Event Type  Injury  
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 Description
Medshape was notified regarding a patient who experienced a fracture of a dynanail post-implantation.
 
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Brand NameDYNANAIL, 10 X 220 MM
Type of DeviceINTRAMEDULLARY FIXATION ROD
Manufacturer (Section D)
MEDSHAPE, INC.
1575 northside dr nw
suite 440
atlanta GA 30318
Manufacturer Contact
nicole corey
1575 northside dr nw
suite 440
atlanta, GA 30318
6782353314
MDR Report Key8804379
MDR Text Key151499144
Report Number3007593722-2019-00001
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K113828
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 07/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Model Number1200-01-1022
Device Lot Number02272
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2019
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received06/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/18/2019 Patient Sequence Number: 1
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