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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PLATE,FIXATION,BONE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PLATE,FIXATION,BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for unknown quantity of unknown plates.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for unknown quantity of unknown plates.Number is not available.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.Device was used for treatment, not diagnosis.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 review of the following journal article: olbrecht, v.Et al (2006), clinical outcomes of noninfectious sternal dehiscence after median sternotomy, the annals of thoracic surgery volume 82, issue 3, pages 902-907 (september 2006) (usa).The purpose of this study was to identify the preoperative characteristics, postoperative complications, and long-term functional outcomes of patients undergoing sternal reoperation from noninfectious causes and to compare these patients with a group of age-, sex-, race-, and procedure-matched control subjects to determine risk factors for noninfectious sternal dehiscence.Retrospective review of the cardiac surgery database identified 48 patients with noninfectious sternal dehiscence in a group of 12,380 median sternotomies between 1994 and 2004.The review included diagnosis, demographics, concomitant medical conditions, and surgical outcomes.Six patients had sternal plates fixed out of the 48 patients.Synthes sternal plate fixation systems (synthes, inc, west chester, pa) were used in patients requiring sternal plates to stabilize the sternum.The types of plates varied in each of the patients, from parallel 2.7 mm or 3.0 mm, depending on the clinical situation.Functional outcomes were assessed using the short form-12 questionnaire.One hundred fifty-six median sternotomy patients served as controls.Follow-up was 97.9% (47 of 48 patients) complete, for a total of 150.1 patient-years.It was not specified which patients were implanted with the synthes plates for revision and which ones experienced the complications.After surgical revision, 14 out of 42 patients experienced mild pain.4 of 42 patients report constant pain at follow-up, and persistent sternal instability occurred in 8 of 41 of patients after the sternal revision.Of the patients who had sternal plates placed, 3 continued to have sternal instability.Approximately 27 of 37 patients experienced no or mild limitations of their physical activities after revision, with 10 of 37 patients experiencing either moderate or severe limitations due to sternal pain and/or instability.This report is for unknown quantity of unknown sternal fixation plates.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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
PLATE,FIXATION,BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8151726
MDR Text Key129947131
Report Number2939274-2018-55351
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received12/07/2018
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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