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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/21/2018
Event Type  malfunction  
Manufacturer Narrative
This report is for one (1) unknown pfna blade. Part#, lot# and udi # is not available. Device is not expected to be returned for manufacturer review/investigation. This report is for one (1) unknown pfna blade. Pma/510(k) number is not available. 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.
 
Event Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported on (b)(6) 2018, during the procedure, aproximal femoral nail antirotation (pfna) nail was not possible to lock as it was not possible to place the locking bolt correctly with the aiming arm. It was noted also that it was not possible to place the blade correctly with the complained aiming arm, the blade hit the nail cranial. It was unknown if there was surgical delay. Patient and procedure outcome are unknown. Concomitant devices: radiolucent insertion handle : (part:03. 010. 405, lot: 8365827, quantity:1). This report is for one (1) unknown pfna blade. This is report 3 of 4 for (b)(4).
 
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Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key8181727
MDR Text Key131156512
Report Number8030965-2018-59185
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup,Followup
Report Date 09/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received04/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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