MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SET SCREW, TI GAMMA3® Ø8X17.5MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3003-0822S

Device Problem Positioning Failure (1158)

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

Event Date 12/15/2021

Event Type  malfunction  

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

Upon completion of investigation, additional information 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 be confirmed, since an insertion of the damaged set screw into a nail is not possible anymore.The device inspection revealed the following: the thread flanks of the set screw are totally flattened, the edge at the forefront has stress marks.The surface of the synthetic locking ring is intact, which indicates that the ring was never in contact with the set screw thread at the nail.The damages at this set screw indicate that this is the in the event description mentioned second set screw that was used during the procedure.A functional test of the set screw was not possible, in the received condition with the totally flattened thread flanks a insertion would be impossible.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by an improper alignment of the set screw at the entry of the connection screw by this it is possible that the set screw get wedged in the connection screw.This would cause a damage of the set screw threads like in this case and with the damaged thread at the set screw a screwing is finally, even with a correct insertion position in the nail, not possible anymore.If more information is provided, the case will be reassessed.

• Brand Name: SET SCREW, TI GAMMA3® Ø8X17.5MM
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13577398
• MDR Text Key: 285955863
• Report Number: 0009610622-2022-00064
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540374844
• UDI-Public: 04546540374844
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K032244
• 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: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3003-0822S
• Device Catalogue Number: 30030822S
• Device Lot Number: K094536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 03/02/2022
• Supplement Dates FDA Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2020
• 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