MAUDE Adverse Event Report: SYNTHES (USA); WIRE, SURGICAL

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Pain (1994); Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article ¿functional and radiographic medium-term outcome evaluation of the humerus block, a minimally invasive operative technique for proximal humeral fractures.¿ bruckers, l., dierickx, c.A., dierickx, c.H., and vundelinckx, b.(2012).Journal of shoulder and elbow surgery, 21, 1197-1206.The authors performed a medium-term outcome evaluation of the humerus block (synthes, (b)(4)), a minimally invasive technique used in selected patients with proximal humeral fractures, to investigate the functional and radiographic outcome.All patients whose humeral fractures were operated with the humerus block system by the same senior surgeon (c.H.D), with follow-up of at least 2.5 years, were selected from our database.A consecutive series of 47 patients (38 women and 9 men) were treated with this technique from july 2003 until january 2008.In 2010, all patients were re-invited for a visit.Of 47 patients operated on with the humerus block, the study group included 34 (including the failure) and was comprised of 26 women and 8 men.The mean age at moment of trauma was 57 years (range: 12-87 years).A simple humerus block was applied in 14 patients, one cannulated screw was added in eight patients, and two cannulated screws were added in 12 patients to stabilize the tuberosity.No intraoperative complications were seen.The repair in one patient was considered a failure because she had undergone a total shoulder arthroplasty after complete avascular necrosis of the humeral head that was detected 19 months postoperatively.The interpretation of the x-ray images showed only one patient with nonunion of the greater tuberosity fragment.There were three radiographically proven cases of avascular necrosis, including the patient who underwent a total shoulder arthroplasty.The shoulder fracture of 1 patient healed with severe impaction of the humeral head with threatening perforation of one of the two pins.In 7 patients, we saw early perforation of one or two k wires into the glenohumeral joint.This made early removal of the pin(s) necessary to avoid further damage to the cartilage.A frozen shoulder developed in two patients, for which mobilization under narcosis was applied during removal of the hardware.A complex regional pain syndrome developed in one patient, proven on a scintigraphic examination.This was finally treated with a neurostimulator, but the end result was poor.The authors concluded: with very satisfied patients; good clinical, functional, and radiographic outcomes; a short hospital stay; few complications; a reduced cost of implant; and a low incidence of avascular necrosis, this technique is a valuable alternative for operative treatment of proximal humeral fractures.This report is for unknown humeral block kirschner wires.There is not sufficient information to file multiple reports.A copy of the journal article is being submitted with this medwatch.

Manufacturer Narrative

Device for treatment, not diagnosis.This report is for unknown humeral block kirschner wires.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 3751865
• MDR Text Key: 4480622
• Report Number: 2520274-2014-10824
• 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: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2014

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: Other
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2014
• Initial Date FDA Received: 04/15/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention