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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DRIVE SHAFT FOR RIA 2 520MM ARTHROSCOPE

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OBERDORF SYNTHES PRODUKTIONS GMBH DRIVE SHAFT FOR RIA 2 520MM ARTHROSCOPE Back to Search Results
Catalog Number 03.404.035
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/13/2020
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or 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.
 
Event Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that the ria2 system was used for sampling a tibial intramedullary canal. The instrument and disposables were assembled correctly. The reamer was introduced into the canal and reaming commenced. After a approximately ten (10)cm of reaming, the head detached from the drive shaft. It was unable to be reconnected. Upon close inspection the head had snapped off at the point it connects to the drive shaft. A replacement head was opened and was very lose fitting on the original drive shaft and the second one from the instrument tray. Reaming recommenced and every time the surgeon withdrew the drive shaft, the head disengaged. The synream was used to complete the procedure with a fifteen (15) minute delay. This report is for one (1) drive shaft for ria 2 520mm. This is report 1 of 4 for (b)(4).
 
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Brand NameDRIVE SHAFT FOR RIA 2 520MM
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key10822778
MDR Text Key219376419
Report Number8030965-2020-08841
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K111437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.404.035
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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