MAUDE Adverse Event Report: STRYKER GMBH TROCHANTERIC NAIL KIT, TI GAMMA3® Ø12X170MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31252170S
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the set screw got stuck in the middle of the nail and the screwdriver for the set was not turning halfway.When tightened hard, it made a creaking sound and the situation was completely different from usual.We tried a new set screw, but the result was the same.We thought that the nail was not good, removed it, open a new difference nail, and perform the operation.The operation took twice as long as usual, putting a burden on the patient, but it was completed successfully.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note the corrections to d1, d4 catalog #, gtin.The reported event could be confirmed, since the device was returned, and matches the alleged failure.The returned trochanteric nail was visually inspected in we can clearly see that the inner threads are completely deformed, and material fragments have started to come off from the threads which indicates that the excessive force was applied while there was improper alignment with the mating part.If we move to the distal side, we can see clearly that the threads have started to flatten up, and the coating on the sides is starting to rub off.These are signs that there was a misalignment with the set screw and application of excessive force.On secondary finding, we can see that the set screw provided with the nail was not used.Functional inspection was performed with the returned nail and a sample set screw in which we can clearly see that due to the sustained damage on the inner threading, the sample set screw also cannot be inserted.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.The root cause of this occurrence can be attributed to user-related as we can see signs of miss alignment.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the set screw got stuck in the middle of the nail and the screwdriver for the set was not turning halfway.When tightened hard, it made a creaking sound and the situation was completely different from usual.We tried a new set screw, but the result was the same.We thought that the nail was not good, removed it, open a new difference nail, and perform the operation.The operation took twice as long as usual, putting a burden on the patient, but it was completed successfully.".

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø12X170MM X 125°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18020538
• Report Number: 0009610622-2023-00370
• Device Sequence Number: 6585725
• Product Code: HSB
• UDI-Device Identifier: 04546540375094
• UDI-Public: 04546540375094
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 31252170S
• Device Lot Number: K0DEBF1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian