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

Catalog Number	14200110
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that: "during an operation on (b)(6) 2025, the surgeon encountered a few difficulties when fitting the nail ref.(b)(4).Apparently, the cephalic screw did not fit into the nail." "mini-abutment of a very complex epiphyseal-diaphyseal fracture.Complex epiphyseal-diaphyseal fracture.Opening of the fascia lata.Drilling of the greater trochanter.Placement of reaming guide nail.Reaming to diameter 13 diaphyseal and 14 metaphyseal.Placement of a nail diameter 10, 125° cervical angulation, 240 length.Placement of the cervical guide pin, which will be checked from front and side.Cervical reaming.Measure length back to 110.Place cervical screw length 110 which will be locked.Place distal screw length to 37.5.Scopic check: technical incidence, given the eccentricity of the cervical screw to the nail.Attempt to reduce the osteosynthesis using the same material was unsuccessful.Patient's current condition: longer operating time (60 min).Actions taken in hospital to manage patient: change of equipment and cerclage of fracture site.Nail length 260, diameter 10, angulation 125°.Placement of guide wire, checked from front and side.Bore length 110.Locked 110 screw in place.Placement of distal screw freehand technique.Scopic control reassuring.".
Additional Manufacturer Narrative
Correction: please refer to sections d9; the device was not returned, and h6 (device code).The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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 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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that: "during an operation on (b)(6) 2025, the surgeon encountered a few difficulties when fitting the nail ref.(b)(4).Apparently, the cephalic screw did not fit into the nail." "mini-abutment of a very complex epiphyseal-diaphyseal fracture.Complex epiphyseal-diaphyseal fracture.Opening of the fascia lata.Drilling of the greater trochanter.Placement of reaming guide nail.Reaming to diameter 13 diaphyseal and 14 metaphyseal.Placement of a nail diameter 10, 125° cervical angulation, 240 length.Placement of the cervical guide pin, which will be checked from front and side.Cervical reaming.Measure length back to 110.Place cervical screw length 110 which will be locked.Place distal screw length to 37.5.Scopic check: technical incidence, given the eccentricity of the cervical screw to the nail.Attempt to reduce the osteosynthesis using the same material was unsuccessful.Patient's current condition: longer operating time (60 min).Actions taken in hospital to manage patient: change of equipment and cerclage of fracture site.Nail length 260, diameter 10, angulation 125°.Placement of guide wire, checked from front and side.Bore length 110.Locked 110 screws in place.Placement of distal screw freehand technique.Scopic control reassuring.".

• Brand Name: GAMMA4 - TARGETING SLEEVE
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21857136
• Report Number: 0008031020-2025-00727
• Device Sequence Number: 18114873
• Product Code: HSB
• UDI-Device Identifier: 07613327479911
• UDI-Public: (01)07613327479911(10)K0FBF99
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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: 14200110
• Device Lot Number: K0FBF99
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2024
• 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