• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (USA); NAIL,FIXATION,BONE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES (USA); NAIL,FIXATION,BONE Back to Search Results
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Event Description
This report is being filed after the subsequent review of the following journal article ¿injury to the infrapatellar branch of the saphenous nerve, a possible cause for anterior knee pain after tibial nailing?¿ leliveld, m., verhofstad, m.(2012).A retrospective review was performed between june 1998 and june 2008 on 72 traumatic tibial shaft fractures, both radiographs and case notes were evaluated retrospectively.The mean follow up time was between 37 to 84 months.All fractures were treated with an unreamed tibial nail (utn; synthes, (b)(4)).Five patients required an immediate fasciotomy.There were four cases of malunion and malalignment occurred three times, one patient had a deep infection.One patient developed a neuroma at the nail entry site which has been resected.Eight locking screws were removed of which three to accomplish dynamisation, the remaining five were removed for they caused pain or discomfort to the patient.Nail exchange occurred three times and four nails were exchanged for a different implant.Bone grafting had been used in three cases.At follow-up 33 of the 72 nails had been removed.Fourteen nails were taken out for they caused general discomfort and twelve nails because of knee pain.A deep infection required nail removal in one patient.Another nail was found to be too short postoperatively and was exchanged.The remaining nails were removed to correct malunion or to achieve union using various implants.Of the 39 nails that were in situ, nineteen were found to be prominent on the lateral radiographs.Sensory deficits related to the infrapatellar nerve were detected in 43 patients.Numbness in the dermatome of the infrapatellar nerve lateral or caudolateral to the incision as an isolated symptom was found in 31 patients.Isolated neuropathic pain in the same area was found in seven patients.A combination of both was detected in five cases.Decreased sensation on the medial side of the calf (distribution area of the sartorial branch of the saphenous nerve) was found in one patient.Another patient suffered from hyperesthesia of the superficial peroneal nerve.Finally, one patient complained of numbness in his first web space without additional symptoms.This report is for an unknown unreamed tibial nail.This is report 3 of 3 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment not diagnosis.Leliveld, m., verhofstad, m.(2012) injury to the infrapatellar branch of the saphenous nerve, a possible cause for anterior knee pain after tibial nailing? injury, int.J.Care injured, 43, pp: 779¿783.This report is for an unknown unreamed tibial nail.(b)(6).Investigation could not be completed and no conclusion could be drawn, as no devices were returned and no lot numbers or part numbers were provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
NAIL,FIXATION,BONE
Manufacturer (Section D)
SYNTHES (USA)
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key4207937
MDR Text Key4963811
Report Number2520274-2014-13913
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 10/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 10/02/2014
Initial Date FDA Received10/28/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-