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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown synthes titanium cannulated hindfoot blade/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. [(b)(4)].
Event Description
This report is being filed after the review of the following journal article: rammelt s et al (2013). Tibiotalocalcaneal fusion using the hindfoot arthrodesis nail: a multicenter study. Foot and ankle international. Volume 34. Pages 1245-1255. (germany). The aim of this study was to examine the clinical experience with a curved nail design and various locking options in the tibia, talus, and calcaneus of the hindfoot arthrodesis nail (han) by different surgeons as well as to document the functional and quality of life outcomes for patients treated with han for severe ankle and foot abnormalities. Between december 2009 and march 2011, 38 patients who underwent ankle arthrodesis using han more than 12 months prior to entering the study, who were at least 18 years of age, and who provided informed consent to participate in the follow-up evaluation surveys were included. There were 19 men and 19 women with a mean age of 53 years (range, 27-81 years). Patients were implanted with an unknown synthes titanium cannulated hindfoot arthrodesis nail. Standard radiographs documenting anatomical alignment of the ankle and hindfoot were obtained in the immediate postoperative period. Follow-up examination data were after a mean period of 23. 6 months (range, 3. 7-39. 3 months). Each patient was asked to assess his or her functional outcome and quality of life status using the american academy of orthopaedic surgeons¿foot and ankle outcomes (aaos-fao) and short form-36 (sf-36) questionnaires, respectively. The degree of pain was also assessed using the 0 to 10 numeric rating scale (nrs)7 where 0 indicated ¿no pain¿ and 10 represented ¿worst possible pain. ¿ complications were reported as follows: 2 patients had an iatrogenic fracture that occurred during surgery. 1 of these patients had a technical problem reported and replacement of the original hindfoot arthrodesis nail (han) was required. 3 patients had valgus deviations of 8 and 10 degrees and a single varus deviation of 6 degrees. 8 patients required aid in their activities of daily living. 6 patients had nonunion. 1 patient had 2 unplanned revision due to nonunion. 1 intervention involved resection of necrotic tissue and bone graft transplantation without nail removal, and in the second procedure the nail was removed followed by bone graft and osteosynthesis with a tibial nail introduced in a retrograde manner 14 months later. 1 patient had nonunion and underwent implant removal followed by osteosynthesis and bone graft. 1 patient had nonunion and underwent talonavicular fusion with a bone graft and screws 8 months after han implantation. 1 patient had nonunion and underwent revision with a bone graft and additional screw fixation of the fibula. 1 patient had nonunion and underwent a second operation 12 months after the primary procedure that involved bone grafting and a dwyer osteotomy of the calcaneus to correct varus malalignment as well as exchanging the han spiral blade for a more proximal locking screw. 1 patient had nonunion associated with a series of complications including a systemic and localized infection and a disassembly- related complication. The patient underwent a 2-stage procedure involving (1) removal of an intramedullary nail and broken plate followed by application of a spacer containing bone cement and gentamycin; and (2) reimplantation of the han with bone grafting 2 months later. The latter, however, resulted in persistent nonunion that required another bone grafting procedure and addition of a lateral plate to provide further stability 9 months after the primary han operation. 1 patient had local soft tissue irritation and the screws were removed. 1 patient had a small wound dehiscence at the anterior approach 2 months after surgery. There was no severe bone infection or material involvement, so the local infection was treated by antiseptic wound dressing until complete wound healing was obtained. 1 patient had an almost maximum degree of pain (nrs
9) at the follow-up evaluation. 1 patient had thromboembolic complication. 1 patient had screw breakage after the completion of surgery. This report captures adverse events of iatrogenic fracture, valgus and varus deviations(malunion), nonunion revised, tissue necrosis, systemic and localized infection, pain, local soft tissue irritation, screw removed and surgical intervention this report is for an unknown synthes titanium cannulated hindfoot blade. This is report 3 of 4 for (b)(4).
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
MDR Report Key8375729
MDR Text Key137317713
Report Number8030965-2019-61519
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/27/2019 Patient Sequence Number: 1