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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

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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 Problems Misassembled (1398); Use of Device Problem (1670); Component Misassembled (4004)
Patient Problem No Code Available (3191)
Event Date 01/21/2019
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (b)(4). It was reported that the insertion angle of the guide wire was not proper. The end cap could not be inserted and assembled to the nail. The incision was extended to attempt to assemble the end cap to the nail. The surgery was completed without the end cap with a reported delay of 30 minutes. A review of the device history records has been requested. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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) 2019, during open reduction internal fixation with trochanteric fixation nail advance (tfna) system that was applied to femoral trochanteric fractures, the tfna end cap in question could not be inserted on the unknown tfna nail. The surgeon removed the unknown insertion handle from the unknown tfna nail and tried to insert the tfna end cap in question over an unknown guide wire with hook using a stardrive screwdriver. However, the insertion angle was not proper, thus, the tfna end cap could not be inserted. The surgeon removed the tfna end cap and rotated the unknown tfna nail to inner direction, and re-tried to insert the tfna end cap. However, it could not be fully inserted in the unknown tfna nail. The surgeon checked the locking mechanism and confirmed that it was engaged properly. The incision was extended and the unknown tfna nail was rotated further. The surgeon re-tried to insert the tfna end cap using an unknown flexible driver but failed. The surgeon gave up inserting the tfna end cap and left the unknown tfna nail in the patient with no tfna end cap. The surgery was completed with a 30-minute delay due to the reported event. There was no adverse consequence to the patient. Concomitant devices reported: unknown insertion handle (part #: unknown, lot #: unknown, quantity: 1), unknown stardrive screwdriver (part #: unknown, lot #: unknown, quantity: 1), unknown flexible driver (part #: unknown, lot #: unknown, quantity: 1). This complaint involves three (3) devices. This report is for one (1) ti end cap for tfna 0mm extn - sterile. This report is 1 of 3 for (b)(4).
 
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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)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key8317952
MDR Text Key135516225
Report Number8030965-2019-60764
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 01/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.000S
Device Lot Number1L61692
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 Received02/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2018
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: 02/07/2019 Patient Sequence Number: 1
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