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

Model Number	2353-3503
Medical Device Problem Codes	Material Fragmentation (1261); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
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
As reported: "the impact tool (ref# 1806-0150) would not screw into the brand new t2alpha femur targeting device (ref# 2353-3503) even after several attempts.Everyone involved at the table tried.Rather, metal shavings were then abraded, but none of them did get into the patient.However, in order to then drive the nail in so as to be able to perform the surgery, the surgeon had to make do and hammered the impactor into the targeting device.".
Event or Problem Description
As reported: "the impact tool (ref# (b)(4) would not screw into the brand new t2alpha femur targeting device (ref# (b)(4) even after several attempts.Everyone involved at the table tried.Rather, metal shavings were then abraded, but none of them did get into the patient.However, in order to then drive the nail in so as to be able to perform the surgery, the surgeon had to make do and hammered the impactor into the targeting device.".
Additional Manufacturer Narrative
Please note corrections d1 (product long description), d3 (manufacturing entity), d4 (catalog # and gtin), and g4 (510k #).The reported event could be confirmed, since the strike plate cannot be attached to the targeting arm anymore in the received condition.The device inspection revealed the following: the visual inspection of the targeting arm has shown that the first three thread flanks of the strike plate thread are completely flattened, most likely caused by the in the description mentioned hammering.It is visible that the intact thread flanks below the damage are slightly worn/discolored and on the top surface are slight stress marks visible.These signs indicate that a strike plate could at some point be fully inserted as intended.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 event was caused by the insertion of strike plate with a thread that was previously damaged into the intact thread of the targeting arm, this did lead to a deformation of the thread flanks and finally to the reported event.If more information is provided, the case will be reassessed.

• 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: 16849249
• Report Number: 0009610622-2023-00141
• Device Sequence Number: 6527176
• Product Code: HSB
• UDI-Device Identifier: 07613327338652
• UDI-Public: 07613327338652
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203819
• 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): 06/21/2023

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 Model Number: 2353-3503
• Device Catalogue Number: 23533103
• Device Lot Number: KP472986
• 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: 04/03/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• 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 Sex: Unknown