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

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.

• Brand Name: TI END CAP FOR TFNA 0MM EXTN - STERILE
• Type of Device: ROD,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 Key: 7441639
• MDR Text Key: 105921761
• Report Number: 8030965-2018-53210
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819648708
• UDI-Public: (01)07611819648708
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.000S
• Device Lot Number: L426925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1