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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: HINDFOOT SPIRAL BLADE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: HINDFOOT SPIRAL BLADE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inflammation (1932)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown hindfoot spiral blade/unknown lot. Part and lot number are unknown; udi number is unknown. Date of implantation is an unknown date between 2009 and 2015. Complainant part is not expected to be returned for manufacturer review/investigation. 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.
 
Event Description
This report is being filed after the review of the following journal article: ersin, m. Et al. (2020), mid-term results of hindfoot arthrodesis with a retrograde intramedullary nail in 24 patients with diabetic charcot neuroarthropathy, acta orthopaedica, vol. 91(3), pages 336-340 (turkey). The aim of this study is to present the mid-term clinical and radiological outcomes of retrograde intramedullary nailing for severe foot and ankle deformity in patients with diabetic charcot neuroarthropathy. Between 2009 and 2015, a total of 24 patients (15 females and 9 males with a mean age of 62 years [33¿82]) underwent unilateral hindfoot arthrodesis using retrograde intramedullary nails. Implants used were the expert han (synthes ag, bettlach, switzerland) in 23 patients and the trigen hindfoot fusion nail (smith & nephew, memphis, tn, usa) in 1 patient. The mean follow-up was 45 months (24¿70). The following complications were reported: 4 patients had superficial infection that were treated successfully with antibiotic and local debridement 1 patient had the spiral blade removed due to retrocalcaneal bursitis. 2 patients had the calcaneal locking screw removed due to retrocalcaneal bursitis. This report is for an unknown synthes expert han (synthes ag, bettlach, switzerland). This is report 1 of 2 for (b)(4).
 
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Brand NameUNK - NAIL HEAD ELEMENTS: HINDFOOT SPIRAL BLADE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11841516
MDR Text Key255920398
Report Number8030965-2021-04006
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
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 Received05/11/2021
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: 05/18/2021 Patient Sequence Number: 1
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