STRYKER SYMMETRY SERIES 1 & 2 STRYKER SYMMETRY 1 & 2 L15007

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-09 for STRYKER SYMMETRY SERIES 1 & 2 STRYKER SYMMETRY 1 & 2 L15007 manufactured by Stryker Medical.

Event Text Entries

[18375321] There was an assembly failure of our stryker recliners. Hairline fractures developed in the wooden frame. There were 102 chairs inspected and all showed cracks. We have had an additional 6 chairs with catastrophic failures that were caught before patient incident. We are categorizing catastrophic failure when the wooden frame is completely broken and unable to support the weight of the chair. ======================manufacturer response for recliner chair, stryker symmetry series 1 & 2======================stryker is building a testing fixture for these specific chairs and will begin to test lifecycle and structural compromise. This will take approximately 3 weeks to perform. Stryker will contact us with results. Stryker was onsite to help us determine the scope of the issue and determined that 100% of the 102 chairs inspected were affected. ====================reporter indicated they believe there were several incidents with these chairs and it will take some time to go through many years of reports. Stryker indicated they were "somehow exceptionally hard on the chairs which had resulted in the breaking/malfunctioning of the chairs" and in "patient/visitor incidents. " chair model number is l15007. Chairs showed "hairline fracture on both sides of the wooden board that connect the back and the bottom of the chair. " they removed the cut the fabric from the back of the chair to look for these fractures. According to the reporter stryker is performing stress tests on the chairs. Stryker sent 20 representatives to the user facility to inspect the chairs. Reporter indicated she has the impression they are not the only facility complaining about the product.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2017990
MDR Report Key2017990
Date Received2011-03-09
Date of Report2011-03-01
Date of Event2011-03-01
Report Date2011-03-01
Date Reported to FDA2011-03-09
Date Added to Maude2011-03-14
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSTRYKER SYMMETRY SERIES 1 & 2
Generic NameRECLINER CHAIR
Product CodeFRJ
Date Received2011-03-09
Returned To Mfg2011-02-21
Model NumberSTRYKER SYMMETRY 1 & 2
Catalog NumberL15007
Lot Number*
ID Number*
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER MEDICAL
Manufacturer Address3800 E. CENTRAL AVE. PORTAGE MI 49002 US 49002


Patients

Patient NumberTreatmentOutcomeDate
10 2011-03-09

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