MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - TROCHANTERIC NAIL KIT, TI D10X170MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31250170S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "periprosthetic fracture was confirmed near the gamma3 nail.The initial surgery date was unknown as it was performed another hospital and there was no data confirmed while over 10 years has been past from the initial surgery.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since provided sequence of x-ray images present a bone fracture out of the area of initial treatment.As per event description ¿the initial surgery date was unknown as it was performed at another hospital and there was no data confirmed while over 10 years has been past from the initial surgery¿ with given details no deficiency for the g3 nail was identified and a link between current occurred fracture and initial nail treatment could not be verified.As pointed out by the labelling ¿the devices are non-active implants intended to provide temporary stabilization for bones or bone fragments¿these devices are intended only to assist healing and are not intended to replace normal bone structures¿ expected lifetime section is referring as follows ¿the lifetime for internal fixation devices is defined by their function in the human body.Internal fixation devices for osteosynthesis are intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved.Adverse effects are clearly pointed out in the ifu and in most instances rather patient related than device related.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
As reported: "periprosthetic fracture was confirmed near the gamma3 nail.The initial surgery date was unknown as it was performed at another hospital and there was no data confirmed while over 10 years has been past from the initial surgery.".

• Brand Name: GAMMA3 - TROCHANTERIC NAIL KIT, TI D10X170MM X 125DEG
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22496738
• Report Number: 0008031020-2025-01078
• Device Sequence Number: 8615497
• Product Code: HSB
• UDI-Device Identifier: 04546540375063
• UDI-Public: 04546540375063
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 31250170S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female