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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - EXTRACTION INSTRUMENTS: TFN/PFN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - EXTRACTION INSTRUMENTS: TFN/PFN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Foreign Body In Patient (2687); No Code Available (3191)
Event Date 08/14/2019
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown tfn extraction instrument/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. 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. (b)(4). 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 the (b)(6) reports an event as follows: it was reported that during a trochanteric fixation nail (tfn) removal procedure on (b)(6) 2019, two extraction instruments broke. The extractor was connected to the nail to remove it. It connected but didn't grab the nail. It would rotate and then split. A second set was opened, and the same thing happened. The nail remained in place in the patient. The surgeon decided to leave fragments of the broken devices in the patient¿s femoral neck. There was an unspecified surgical delay. Concomitant devices: screw (part: unknown, lot: unknown, quantity: unknown); tfn nail (part: unknown, lot: unknown, quantity: 1). This report is for an unknown tfn extraction instrument. This is report 2 of 2 for (b)(4).
 
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Brand NameUNK - EXTRACTION INSTRUMENTS: TFN/PFN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9008404
MDR Text Key161812267
Report Number8030965-2019-68206
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 08/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2019
Is this an Adverse Event Report? Yes
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 Received11/08/2019
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

Patient Treatment Data
Date Received: 09/12/2019 Patient Sequence Number: 1
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