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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 Problem Device Operates Differently Than Expected (2913)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 03/30/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information not available for reporting. Device malfunctioned intra-operatively and was not implanted/explanted. Subject device has been received and is currently in the evaluation process. 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 patient underwent an open reduction internal fixation (orif) procedure for femoral fractures on (b)(6) 2018. The trochanteric fixation nail advanced (tfna) system was implanted. Surgeon had difficulty attaching the titanium end cap for tfna. Multiple attempts were made utilizing other insertion instruments without success. Surgeon made the incision larger and tried again but also failed. Surgeon then completed the procedure without inserting the end cap. Surgery was completed successfully with a delay of approximately 30 minutes. No adverse consequence to the patient was reported. This report is for one (1) titanium end cap for tfna. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Part: 04. 038. 000s; lot: l426925; manufacturing location: (b)(4); release to warehouse date: june 23, 2017; expiry date: june 01, 2027; no nonconformance reports (ncrs) were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Investigation site: (b)(4); selected flow: damage / deformed. Visual investigation: one 04. 038. 000s / titanium end cap for trochanteric fixation nail advanced t(fna) extended was received for investigation. The device is intact but shows various damage and wear. The m11x1 thread is unusable because of the damage. The outside diameter is reduced and the thread flanks are deformed and worn. The stardrive t40 recess has marks and is outworn. There are striations on the guiding pivot run-in area. All described damages were caused post-manufacturing as the anodized color was abraded. As the thread of the end cap is damaged, it cannot be fixed to the nail anymore; the received condition agrees with the complaint description and the complaint therefore is confirmed. Dimensional inspection: because of the existing damage on the complaint relevant m11x1 thread, a dimensional inspection cannot be conducted and is not required per selected investigation flow because of use-related damage. Drawing/specification review: the investigation has shown that the cause of the malfunction is a damage to the device after manufacture, therefore no drawing / specification test is required. Conclusion: the manner of damage and wear present the application of incorrect surgical alignment procedures and mechanical overload. The tfna advanced surgical technique guide (page 69) states that ¿a guide wire can be used to help ensure alignment while inserting the end cap. ¿ because of the post manufacturing existing damage, all complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications. The dhr review shows that the device met fully to our specifications at the time of manufacturing in june 2017 and there were no issues that would contribute to this complaint condition. A final manufacturing determination cannot be drawn because of the condition of the product. The most probable root cause is application of excessive force caused during incorrect surgical alignment procedures. No manufacturing related issue was identified and/or confirmed. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. (b)(4). 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.
 
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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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7441639
MDR Text Key105921761
Report Number8030965-2018-53210
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 03/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.000S
Device Lot NumberL426925
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/23/2017
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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