MAUDE Adverse Event Report: STRYKER GMBH TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23533103
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "case: removal of metal work (synthes blade plate) with timex kit.Revise using alpha antegrade nail.It was reported that all the crown drills were blunt.Another company¿s kit had to be opened to remove the broken screws from the blade plate.The recon drill and screw were inserted into position b, however when it came to position a the drill and screw missed the nail.The surgeon had to drill and advance the screw free hand without the use of the targeting arm.The procedure likely took longer and the team had to open several additional kits - another company¿s screw removal kit, another company¿s cannulated drill kit, and stryker¿s asnis 6.5mm cannulated screw kit.I would estimate around 20-30 minutes for the timex portion, and 30-45 minutes for the recon screw.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device was found to be functional and within specifications.The device inspection revealed the following: the received targeting arm shows normal signs of usage with no significant damage or worn off signs.Visually the device was alright from all aspect.The returned targeting arm was assembled with the returned devices including nhs, sleeves and screwdriver bit and a sample nail.All the desired functions in each position could be achieved with the targeting arm.The alleged event could not be reproduced hence could not be confirmed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the issue is deemed to be user related since the alleged issue could not be reproduced.The function of targeting arm along with all the other devices was given as intended.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "case: removal of metal work (synthes blade plate) with timex kit.Revise using alpha antegrade nail.It was reported that all the crown drills were blunt.Another company¿s kit had to be opened to remove the broken screws from the blade plate.The recon drill and screw were inserted into position b, however when it came to position a the drill and screw missed the nail.The surgeon had to drill and advance the screw free hand without the use of the targeting arm.The procedure likely took longer and the team had to open several additional kits - another company¿s screw removal kit, another company¿s cannulated drill kit, and stryker¿s asnis 6.5mm cannulated screw kit.I would estimate around 20-30 minutes for the timex portion, and 30-45 minutes for the recon screw.".

• Brand Name: TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE
• 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: 19563776
• Report Number: 0009610622-2024-00289
• Device Sequence Number: 6197817
• Product Code: HSB
• UDI-Device Identifier: 07613327338652
• UDI-Public: 07613327338652
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: 23533103
• Device Lot Number: KP431228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male