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

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).

• Brand Name: UNK - END CAPS
• Type of Device: ROD, 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 Key: 11694894
• MDR Text Key: 246443373
• Report Number: 8030965-2021-03083
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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 Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention