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

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.

• 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 Key: 4207937
• MDR Text Key: 4963811
• Report Number: 2520274-2014-13913
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• 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

• Date FDA Received: 10/28/2014
• 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: 10/02/2014
• 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