MAUDE Adverse Event Report: STRYKER GMBH PLUS TARGETING ARM GAMMA4; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	14200120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that during a case for an intertrochanteric fracture, the nail attached to the targeter was impacted using the appropriate impactor.After confirming the positioning via x-rays, it was observed that the targeter and nail had separated.The surgical team removed the targeter and hardware and proceeded with a different implant system (gamma 3 instead of gamma 4).The surgery was completed, with no adverse patient consequences or need for medical intervention, though there was a slight surgical delay.
Additional Manufacturer Narrative
Correction to d9 (product available to stryker), h3 (device evaluated by mfg), h6 (method code, results code , conclusion code).The reported event could be confirmed as the device was returned and matches the alleged failure.The received targeting arm was visually inspected, cracked from the center, dividing the carbon portion into two halves.The metal portion has completely come off from the assembly thread section the metal portion is stuck with the nail and nail holding screw.We also see brushing marks on the grabbing handle of the arm.The threaded portion of the metal part was observed with nick and dent marks.The functional inspection was conducted with the returned metal part by trying to fit it into the targeting arm, but it could not be fully inserted it could be inserted by the half section only which could be due to nicks in thread as well as due to the crack generation on the targeting arm.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 the investigation root cause can be attributed to user related damage is caused due to the application of high force while the insertion of the nail holding screw.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that during a case for an intertrochanteric fracture, the nail attached to the targeter was impacted using the appropriate impactor.After confirming the positioning via x-rays, it was observed that the targeter and nail had separated.The surgical team removed the targeter and hardware and proceeded with a different implant system (gamma 3 instead of gamma 4).The surgery was completed , with no adverse patient consequences or need for medical intervention, though there was a slight surgical delay.

• Brand Name: PLUS TARGETING ARM GAMMA4
• 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: 20510618
• Report Number: 0009610622-2024-00884
• Device Sequence Number: 20594229
• Product Code: HSB
• UDI-Device Identifier: 07613327590098
• UDI-Public: 07613327590098
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K230512
• 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): 01/15/2025

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: 14200120
• Device Lot Number: KP494402
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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