OSCILL-SAW 518.010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for OSCILL-SAW 518.010 manufactured by Depuy Synthes Products Llc.

Event Text Entries

[186532419] 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. This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. However, since the investigation is still on-going, the assignable root cause could not be determined at this time. Once investigation has been completed, a supplemental medwatch will be submitted accordingly. Udi: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[186532420] It was reported from (b)(6) that during service and evaluation, it was determined that the oscillating saw attachment device had insufficient/low power, component damage, worn housing and worn bearing. It was further determined that the device failed pretest for check general condition and check oscillation frequency. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2020. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8030965-2020-02332
MDR Report Key9889777
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-27
Date of Report2020-03-18
Date of Event2020-01-01
Date Mfgr Received2020-03-18
Device Manufacturer Date2004-04-27
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. KARA DITTY-BOVARD
Manufacturer StreetEIMATTSTRASSE 3
Manufacturer CityOBERDORF 4436
Manufacturer CountrySZ
Manufacturer Postal4436
Manufacturer Phone6103142063
Manufacturer G1OBERDORF SYNTHES PRODUKTIONS GMBH
Manufacturer StreetEIMATTSTRASSE 3
Manufacturer CityOBERDORF 4436
Manufacturer CountrySZ
Manufacturer Postal Code4436
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOSCILL-SAW
Generic NameINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Product CodeHWE
Date Received2020-03-27
Returned To Mfg2020-02-25
Catalog Number518.010
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDEPUY SYNTHES PRODUCTS LLC
Manufacturer AddressEIMATTSTRASSE 3 OBERDORF 4436 SZ 4436


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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