MAUDE Adverse Event Report: SYNTHES USA; WIRE, SURGICAL

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Aschauer, e., hubner, c., resch, h.(2007) percutaneous osteosynthesis of humeral head fractures.Oper orthop traumatol, 19: 276-93.This report is for unknown - kirschner wire/unknown quantity/unknown lot.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the subsequent review of the following literature article, aschauer, e., hubner, c., resch, h.(2007) percutaneous osteosynthesis of humeral head fractures.Oper orthop traumatol, 19: 276-93.The purpose of this article is to evaluate the reduction and fixation of displaced fractures of the humeral head by percutaneous methods.Long-term outcomes after a period of at least 2 years have been documented for 200 patients (24-81 months) postoperatively.The patient sample consisted of 122 women (61%) and 78 men (39%).The average age was 61.6 years (14-103 years).Average surgery time was 31 min, average radiation time 3.2 min.Complications: a second operation was necessary for 24% of patients.In ten cases (5%) there was recurrent perforation of the wires through the humeral head cortex.The kirschner wires were retracted to prevent irritation with consequent damage to the glenoid.In 13% of cases the osteosynthesis proved to be too unstable and reosteosynthesis was required.In 3% a varus head deformity of up to 15ࠄeveloped, in 2% there was valgus subsidence of the head fragment, and, finally, in 4% there was unacceptable medialization of the shaft.In 9% at least partial head necrosis developed but was only clinically relevant in 3% and led to secondary implantation of a joint prosthesis.In another 3% of fractures the bone failed to consolidate.A pseudarthrosis developed and was treated by application of an angled-blade plate without cancellous bone graft.A copy of the literature article is attached to this medwatch.This is report 1 of 2 for com-(b)(4).This report is for an unknown - kirschner wire and refers to second operation for 24% of patients and in ten cases (5%) there was recurrent perforation of the wires through the humeral head cortex.

• Type of Device: WIRE, SURGICAL
• 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: 5024383
• MDR Text Key: 23799514
• Report Number: 2520274-2015-15406
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 08/17/2015

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2015
• 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