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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 Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/12/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information is not available for reporting. This report is for an expert tibial nail. Part and lot numbers are unknown. Without the specific part and lot number, the udi is not available. Device is implanted; as such explant date is not applicable. Complainant device is not expected to be returned for manufacturer review/investigation. Facility address and reporter phone number not provided for reporting. The (510k): unknown, as specific part and lot numbers for nail is not provided. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 that during a surgery on (b)(6) 2018, after implanting the nail and backstroking it for compression, surgeon was not able to remove the nail from the insertion handle. Too much stress was on the connection, the surgeon even broke the screwdriver. The surgery was prolonged for about 30 minutes. The surgery was successfully completed with no patient harm. All the broken off fragments could not be removed from the patient. This report is for an unknown expert tibial nail. This is report 2 of 3 for complaint (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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7477740
MDR Text Key107082447
Report Number8030965-2018-53486
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2018
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 Received04/13/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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