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U.S. Department of Health and Human Services

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

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SYNTHES (USA); WIRE, SURGICAL Back to Search Results
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.
 
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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 Key3751865
MDR Text Key4480622
Report Number2520274-2014-10824
Device Sequence Number1
Product Code LRN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received04/15/2014
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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