MAUDE Adverse Event Report: STRYKER GMBH PLUS NAIL HOLDING SCREW GAMMA4; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	14200125
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
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
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
The reported event could be confirmed as the device was returned and matches the alleged failure.The nail-holding screw was stuck into the metal portion of the targeting arm, the damage is visible in the head of the screw where the screwdriver is inserted.We can see heavy deformation which is caused by the screwdriver rubbing into it with heavy force as the nail-holding screw stuck inside the metal portion of the 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 as the device the deformation on the head indicates to application of high force.If any additional information is provided, the investigation will be reassessed.

• Brand Name: PLUS NAIL HOLDING SCREW 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: 20510552
• Report Number: 0009610622-2024-00882
• Device Sequence Number: 8497656
• Product Code: HSB
• UDI-Device Identifier: 07613327571998
• UDI-Public: 07613327571998
• 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: 14200125
• Device Lot Number: UNKNOWN
• 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
• 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