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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE PERF L90 TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE PERF L90 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.390S
Device Problems Device Damaged by Another Device (2915); Device-Device Incompatibility (2919); Migration (4003)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown nail head elem-tfna hel/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. (b)(4). The reported event required medical/surgical intervention to preclude permanent damage to a body structure. The blade and distal locking screw will remain coded for migration. 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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, a patient underwent a second surgery to review a trochanteric fixation nail advance (tfna) nail that presented mobility after insertion in the primary surgery where it was cast on (b)(6) 2018. The surgeon alleges that the mobility of the nail was due to the failures presented by the instruments in the surgery. The instruments they carried brought a damaged piece. Still, the surgeon made the decision to put the nail, as he did not realize that the piece was damaged until later. Therefore, the surgeon decided to put the implant. Subsequently, the implant was moved inside the femur, which could be caused by a poor technique at the time of place. Patient and procedure outcome is unknown. This complaint involves three (3) devices. This report is for (1) unk - nail head elements: tfna helical blade. This report is 1 of 3 for (b)(4).
 
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Brand NameTFNA HELICAL BLADE PERF L90 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf PA 4436
SZ 4436
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8238607
MDR Text Key132767759
Report Number2939274-2019-55785
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeMX
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 12/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.390S
Device Lot NumberH488767
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/10/2019 Patient Sequence Number: 1
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