MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3125-1180S

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event Description

As reported: "surgeon is performing a gamma operation.When he is to place the set screw he is not able to get the set screw to connect with the lag screw.The set screw is locked in the nail before it connects with the lag screw.They try with another set screw and gets the same result.They then remove the nail and try outside the patient.Again the same result.Both set screws are tightened in the nail before reaching the lag screw.They then took a new nail with another lot no.And were then able to perform the operation." the patient was unnecessarily under anesthesia for an hour where the surgeon and nurses tried to find a solution.

Manufacturer Narrative

The reported event could not be confirmed since the returned devices are conforming to specifications and fully functional.The device inspection revealed the following: the visual inspection has shown that the returned nail and the set screw are intact, there are no visible damages at the devices and there is no indication that these devices were implanted.The thread of the set screw and as well the thread in the nail are intact and there are no wear marks visible.The synthetic locking ring has no visible impression marks that would indicate that the screw was inserted into a nail once.A functional test with the nail was performed with the returned intact set screw from lot the same lot k0cb3f4 and with the set screw from the unopened kit that was returned without allegation.It was possible to insert both set screws into the nail as required, there was slight resistance during the insertion, which is normal and can be tracked back to the function of the synthetic locking ring at the set screw.During the test it was also possible to lock the lag screw as required, the complained malfunction could not be reproduced.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.No product related issue could be detected, the devices of the nail kit that was investigated under this complaint with the reference # (b)(4) are functional as required, therefore this complaint will be closed without further action.If more information is provided, the case will be reassessed.

Event Description

As reported: "surgeon is performing a gamma operation.When he is to place the set screw he is not able to get the set screw to connect with the lag screw.The set screw is locked in the nail before it connects with the lag screw.They try with another set screw and gets the same result.They then remove the nail and try outside the patient.Again the same result.Both set screws are tightened in the nail before reaching the lag screw.They then took a new nail with another lot no.And were then able to perform the operation." the patient was unnecessarily under anesthesia for an hour where the surgeon and nurses tried to find a solution.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: nathe hendricks ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13235314
• MDR Text Key: 283664798
• Report Number: 0009610622-2022-00009
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375070
• UDI-Public: 04546540375070
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3125-1180S
• Device Catalogue Number: 31251180S
• Device Lot Number: K0CB3F4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1