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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 Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/29/2017
Event Type  malfunction  
Manufacturer Narrative
A review of the provided x-ray was completed. Provided x-ray was reviewed but the complained issue (the procedure was ended as the tip of the blade was slightly protruded from the outer cortical bone) could not be confirmed as only one image was sent and the complained issue is not clearly visible. 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.
 
Manufacturer Narrative
Patient information was not provided for reporting. This report is for one (1) unknown tfna helical blade. Part#, lot# and udi # is not available. Device malfunctioned intraoperative. Device was not implanted/explanted. Device is not expected to be returned for manufacturer review/investigation. Reporter contact number was not provided. This report is for one (1) unknown tfna helical blade. Pma/510(k) number is not available. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review could not be completed without lot number. 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 the patient underwent surgery for the femoral trochanteric fracture on (b)(6) 2017. The tfna was used for the procedure. Although the surgeon inserted the nail and the blade, it turned out at the end that the blade could not be installed in a right position. The procedure was ended as the tip of the blade was slightly protruded from the outer cortical bone. No delay in surgery or adverse consequence to the patient was reported. It is unknown if another blade was used to complete the surgery. Concomitant devices reported: tfna fem nail ø10 125° (part# 04. 037. 012s, lot# unknown, quantity 1). Connecscr f/insertion handle (part# 03. 037. 010, lot# unknown, quantity 1). Insert-handle hybrid (part# 03. 037. 011, lot# unknown, quantity 1). Aim-arm 125° f/stat+dyn dist lock (part# 03. 037. 114, lot# unknown, quantity 1). Buttress/compr-nut (part# 03. 037. 016, lot# unknown, quantity 1). Guide sleeve yell (part# 03. 037. 017, lot# unknown, quantity 1). This report is for one (1) unknown tfna helical blade. This is report 1 of 1 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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7155038
MDR Text Key250691244
Report Number8030965-2017-51019
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2017
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 Received01/18/2018
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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