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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - END CAPS ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH UNK - END CAPS ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Device Slipped (1584)
Patient Problem Physical Asymmetry (4573)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown elastic nail end cap/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. 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.
 
Event Description
This report is being filed after the review of the following journal article: nectoux e, et al. (2008), use of end caps in elastic stable intramedullary nailing of femoral and tibial unstable fractures in children: preliminary results in 11 fractures, j child orthop, volume 2, pages 309-314, (france). The purpose of this study is to evaluate the efficiency, safety and tolerance of this new device in our first series of ten patients and 11 fractures. Between january 2005 and december 2006, 10 patients with 11 unstable femoral or tibial shaft fractures were treated by elastic stable intramedullary nailing (esin) using end caps. The ages of the children ranged from 7 to 15 years (mean 10 years); the young girl with fibrous dysplasia was (b)(6) years old. Their weights ranged from 17 to 56 kg. There were 3 girls and 7 boys, with 1 of the boys having both femoral and tibial fractures. Patients were implanted with stainless steel nails, with diameters ranging from 3 to 4 mm depending on the child¿s weight and age, are inserted retrograde for the femoral fractures and antegrade for both tibial fractures. An unknown ao end cap is then inserted onto the tip of the nail with an appropriate screwdriver and the nail is screwed into the cortical bone under fluoroscopic control, ensuring that the end cap¿s thread has a firm grip in the cortical bone. Each patient was followed up post-operatively for complications and bone healing. The mean follow-up was 13. 1 months. All nails were removed 4¿ 7 months after the initial surgery. Complications were reported as follows: 1 patient had difficulties encountered in inserting the end cap in the medial nail intraoperatively. It was impossible to screw the end cap into the bone cortex. 1 patient had difficulties encountered in inserting the end caps in both lateral and medial nails intraoperatively. The end caps were held rather loosely in the bone. The patient had 10 mm shortening of the limb during the immediate postoperative examination. During the last follow-up visit occurred 10¿24 months after the initial surgery, the patient¿s fracture only partially remodeled. 1 patient had internal rotation greater than 10 degrees during the immediate postoperative examination. 3 patients had fractures that only partially remodeled, 1 of which was the case with 2 loose end caps. 1 patient had mild shortening of the limb between 5 and 10mm. This report is for the unknown elastic stable intramedullary nailing (esin) end cap. It captures the reported adverse event of difficulties in inserting the end cap, caps held loosely in the bone, patient had 10 mm shortening of the limb and fracture only partially remodeled. This is report 1 of 2 for (b)(4).
 
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Brand NameUNK - END CAPS
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key11694894
MDR Text Key246443373
Report Number8030965-2021-03083
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received04/02/2021
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: 04/20/2021 Patient Sequence Number: 1
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