MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 9MM/125 DEG TI CANN TFNA 170MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.037.912S

Device Problem Device-Device Incompatibility (2919)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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) 2020, the patient underwent open reduction internal fixation surgery for femoral trochanteric fracture with the trochanteric fixation nail advanced (tfna) nail.During the surgery, the locking mechanism of the tfna nail didn¿t work properly.The surgeon used unknown screwdriver and locked the nail again, but the screwdriver was idling.The surgeon removed the implants and used another nail.The locking mechanism worked properly, and the surgery was completed successfully with forty (40) minutes delay.The scheduled surgery time was one (1) hour.After the surgery, the surgeon checked the nail in question and tried to lock the locking mechanism of the nail, but it wasn¿t locked.The surgeon applied the strong force, and the locking mechanism worked properly.Patient outcome is reported as stable.No further information is available.Concomitant devices reported: unknown screwdriver (part# unknown, lot# unknown, quantity# 1).This report is for one (1) 9mm/125 deg ti cann tfna 170mm - sterile.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: part 04.037.912s, lot 28p8430: release to warehouse date: november 18, 2019.Expiration date: november 01, 2029.Supplier: jabil-monument.No non-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.H3, h6: a product investigation was completed: the top of the locking mechanism is in a very used condition, there are very strong stress marks on the top surface and the hexagon recess is totally worn.The locking prong at the forefront of the mechanism is in a good condition with no visible damage.The blade hole has heavy stress marks at the inside, most likely caused by an excessive contact with a reamer.The anodized layer is not present anymore at all damages, which indicates that they were caused post-manufacturing.During the evaluation a function test was completed, and the complained malfunction of the locking mechanism could not be replicated.It was possible to move the mechanism back and forth without any issues, also it was possible to lock a blade in different blade positions.The visual damages have no influence on the function of the device.The tfna surgical technique was reviewed and following statement from the assemble insertion instruments section, it is mentioned: to verify the appropriate position of the locking mechanism for the screw, pass the 5.0 mm flexible screwdriver through the cannulated connecting screw and turn counter-clockwise until it stops.The complained malfunction regarding the functionality of the locking mechanism could not be replicated during the performed evaluation.Nevertheless, is the complaint rated as confirmed due to the strong visible damages at the locking mechanism.During the performed evaluation no manufacturing related issue could be detected.Based on the provided information the exact cause of the complained malfunction cannot be determined.The very strong stress mark on top of the locking mechanism and the worn hexagon could be an indication for an excessive contact between the connecting screw for insertion handle; either the connecting screw was tightened onto the too high positioned mechanism or the mechanism was over-tightened when it was turned back as described in the surgical technique.Both could lead to a jamming and malfunction of the locking mechanism.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 9MM/125 DEG TI CANN TFNA 170MM - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10779176
• MDR Text Key: 214393297
• Report Number: 8030965-2020-08518
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819651708
• UDI-Public: (01)07611819651708
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.912S
• Device Lot Number: 28P8430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Date Manufacturer Received: 11/26/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS; UNK - SCREWDRIVERS
• Patient Age: 92 YR