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	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "distal locking not possible in gamma3 surgery with aiming sleeves and insertion guide, hole above sleeves does not meet locking hole of the implant.Freehand-locking hat to be performed to successfully complete the procedure.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was returned for evaluation and found to be fully functional.The received targeting device was visually inspected in we can see slight deformation at the proximal hole, and we see heavy deformation at the assembly point of the strike plate which is formed by hitting over a while perpendicularly and horizontally.A functional inspection was carried out with the received targeting arm, sleeve, and sample drills, inspection was conducted for the proximal and distal holes where no miss-drilling was observed functionality of the device was given.A functional inspection was also conducted with a sample strike plate which was not able to be assembled properly due to damage initial mating threads.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 a functional inspection was carried out on the device which confirms the functionality of the device and the deformation around the device indicates towards improper handling of device.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "distal locking not possible in gamma3 surgery with aiming sleeves and insertion guide, hole above sleeves does not meet locking hole of the implant.Freehand-locking hat to be performed to successfully complete the procedure.".

• 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: 19680368
• Report Number: 0009610622-2024-00339
• Device Sequence Number: 11566213
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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: KME906192
• 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: 06/06/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2014
• 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