• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI END CAP FOR TFNA 0MM EXTN - STERILE ROD,FIXATION,INTRAMEDULLARY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OBERDORF SYNTHES PRODUKTIONS GMBH TI END CAP FOR TFNA 0MM EXTN - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.000S
Device Problem Device Difficult to Maintain (3134)
Patient Problem No Patient Involvement (2645)
Event Date 01/09/2019
Event Type  malfunction  
Manufacturer Narrative
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. The investigation could not be completed; no conclusion could be drawn, as no product was received. Investigation summary of product development investigation. The reported event does not describe a dysfunction or a design deficiency but a customer feedback. The modifications requested by the surgeon are not clear or/and not possible to implement for following reasons: make the thread pitch longer¿: pitch / thread of the endcap (pitch and length) is designed to avoid collision with the end of the thread in the nail and with the locking prong. The length of the thread does furthermore have no influence of the ease of insertion of the end cap into the nail. Change the design so that the screw is held with the screwdriver firmly ¿: the screw interface cannot be designed to be firmly hold by the screwdriver as the self-holding feature is on the screw driver side and the ball shape of the screwdriver tip does not allow to have a self-holding feature. The retention of the endcap can be enabled by the use of a guide wire. Change the design so that the acceptable range of the end cap insertion becomes wider¿: the angulation of the screwdriver with the endcap is limited by the cannulation in the screwdriver shaft. Increasing the possible angulation of the end cap with the screwdriver would weaken the screwdriver shaft and / or make the stardrive feature not retained on the shaft. The reported event does not describe a dysfunction or a design deficiency but a customer feedback regarding the function of the products that can't be improved or changed and that where verified and validated. 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. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during an unknown surgery a trochanteric femoral nail advanced (tfna) system was applied for femoral trochanteric fractures. During surgery, the surgeon had a difficulty in insertion and tightening an end cap using a screwdriver due to following reasons: (1) the pitch of threads on an end cap is short , thus clearance was small; (2) an end cap was detached from the driver shaft; (3) due to an unknown guide wire with hook, an acceptable range of angle for inserting the end cap was limited; (4) and the tip of the driver shaft could not be bent. So, the surgeon requested to change the design as follows: make the thread pitch longer, change the design so that the screw is held with the screwdriver firmly, and change the design so that the acceptable range of the end cap insertion becomes wider. The procedure was successfully completed with a 30 minutes surgical delay reported. There was no adverse consequence to the patient. Concomitant devices reported: unknown guide wire ( part # unknown, lot # unknown, quantity 1) unknown screwdriver shaft ( part # unknown, lot # unknown, quantity 1). This complaint involves three (3) devices. This report is 1 of 3 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTI END CAP FOR TFNA 0MM EXTN - STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key8283603
MDR Text Key134332806
Report Number8030965-2019-60443
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160167
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 01/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.000S
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 Received02/08/2019
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

-
-