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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAILS: TFNA ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAILS: TFNA ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Calcium Deposits/Calcification (1758); Pain (1994)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Date of event is an unknown date in 2019. This report is for an unknown tfna nail/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a synthes employee. 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) 2019, a patient underwent an unknown procedure to treat a fracture with the trochanteric fixation nail advanced (tfna) system. Reportedly, on (b)(6) 2019, the patient presented with mild distal ossification of intramedullary nail which is ongoing and unchanged. Concomitant devices: tfna helical blade (part: unknown, lot: unknown, quantity, 1). This report is for an unknown tfna nail. This is report 1 of 2 (b)(4).
 
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Brand NameUNK - NAILS: TFNA
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 Key9124332
MDR Text Key165389601
Report Number8030965-2019-68732
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCH
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 05/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received01/13/2020
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

Patient Treatment Data
Date Received: 09/26/2019 Patient Sequence Number: 1
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