MAUDE Adverse Event Report: STRYKER GMBH TARGET DEVICE GAMMA3®; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	13200111
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
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: "there were repeated incorrect drillings in the lag screw drilling of the gamma3 nail via the aiming bracket and aiming sleeve.Screw could not be placed in g3 nail.Operation times have been extended by 20 min.".
Additional Manufacturer Narrative
The reported event could not be confirmed during the inspection.The device inspection revealed the following: the identification of the returned device was confirmed based on the catalog # and lot # marked.No major sign of wear or deformation could be observed on the target device.Fully functional devices (guide sleeve, step drill, lag screw, lag screwdriver, nail, nail holding screw and speedlock sleeve) were used in order to simulate the drilling and lag screw insertion steps on the returned target device.Both steps could be performed without any issue, the step drill and the lag screw were fully centered in the lag screw hole of the nail, as required.Therefore, no problem could be observed on the target device and the reported issue could not be confirmed.During manufacturing, a dimensional inspection was done according to specifications.During the inspection, all devices met the specifications.Based on investigation, the root cause of the reported event could not be identified, as it was confirmed that the device is fully functional.A nc and a capa were previously opened (and closed) in order to cover such event.Result of the investigation in the nc and in the capa: "the investigation reveals that the returned targeting devices fulfill the functionality testing and show that there is no limits in regards to drilling accuracy.Handling under surgical condition could vary within different countries." 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 more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "there were repeated incorrect drilling's in the lag screw drilling of the gamma3 nail via the aiming bracket and aiming sleeve.Screw could not be placed in g3 nail.Operation times have been extended by 20 min.".

• Brand Name: TARGET DEVICE GAMMA3®
• 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: 18301733
• Report Number: 0009610622-2023-00446
• Device Sequence Number: 7152131
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: 04546540716774
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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: 13200111
• Device Lot Number: KME917489
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2022
• 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