DE MAYO KNEE POSITIONER
Received Apr 28, 2020
Report 1223419-2020-00001 · MDR key 10007109
Device
Generic name
De Mayo Knee Positioner
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
WE RECEIVED 2 SUS VOLUNTARY EVENT REPORTS ONE (MW5092979) WAS REPORTED AS A MALFUNCTION AND THE OTHER (MW5093012) WAS REPORTED AS A SERIOUS INJURY WITH A REQUIRED INTERVENTION. THE EVENT DESCRIPTIONS ARE IDENTICAL SAVE A FEW SPELLING CHANGES BETWEEN THEM. THIS SHOWS THAT THEY CAME FROM THE SAME FACILITY AND/OR PERSON ONE DAY APART, HOWEVER; WITH NO CONTACT INFORMATION OR OTHER IDENTIFYING CHARACTERISTICS FILLED OUT ON EITHER OF THE FORMS WE CANNOT EFFECTIVELY CONTACT, COMMUNICATE OR OTHERWISE UNDERSTAND HOW SOMEONE WAS SERIOUSLY INJURED. THE EVENT DESCRIPTIONS DO NOT INDICATE THAT ANYONE WAS INJURED ONLY POINTING OUT A CLEANING CONCERN FROM SPD. BECAUSE CLEANING AND STERILIZATION VALIDATIONS HAVE BEEN DONE ON THE PRODUCT THE SPD CONCERNS LIKELY STEM FROM INCORRECT CLEANING AND STERILIZATION I.E. NOT FOLLOWING IFU. - : [MAUDE MW5093012.PDF, MAUDE MW5092979.PDF]
Description of Event or Problem
UNKNOWN, THE PERSON/ FACILITY THAT SENT MAUDE REPORT DID NOT GIVE ANY INDICATION OF WHAT THE INJURY WAS.