MAUDE Adverse Event Report: STRYKER GMBH SET SCREW GT T2 ALPHA FEMUR ANTEGRADE Ø8; SCREW, FIXATION, BONE

Catalog Number	23310000S
Medical Device Problem Codes	Positioning Failure (1158); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Set screw was moving freely even when it was fully in nail without any resistance.Surgeon take it out and put 0mm cap and finished the operation.
Additional Manufacturer Narrative
The reported event could not be confirmed since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: overall, the set screw is in correct condition: no significant deformation or breakage can be observed.The screw head is worn out, most likely due to several attempts using the set screwdriver.The threads are also worn out, once again most likely due to several unsuccessful screw insertion attempts in the nail.A functional inspection was performed.The received set screw was inserted into a compatible and functional femoral nail gt, left t2 alpha femur antegrade 10x240mm.The set screw was successfully inserted into the nail without any loosening or insertion issue observed.The reported incident could not be reproduced, therefore the event cannot be confirmed.The root cause of the reported incident could not be determined.As aforementioned, the set screw worked as intended, with no issue being observed.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.If more information is provided, the case will be reassessed.
Event or Problem Description
Set screw was moving freely even when it was fully in nail without any resistance.Surgeon take it out and put 0mm cap and finished the operation.

• Brand Name: SET SCREW GT T2 ALPHA FEMUR ANTEGRADE Ø8
• Common Device Name: SCREW, FIXATION, BONE
• 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: 19916360
• Report Number: 0009610622-2024-00731
• Device Sequence Number: 7244617
• Product Code: HWC
• UDI-Device Identifier: 07613327343113
• UDI-Public: 07613327343113
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 23310000S
• Device Lot Number: K18D1CE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• 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
• Patient Age: 55 YR
• Patient Sex: Unknown
• Patient Weight: 82 KG