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

Model Number 1320-0111

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "there was a misdrilling in the distal locking of the g3 nail using the aiming handle and aiming sleeve.Failed to place distal screw in g3 nail.Drills broke off 2x when trying to lock via aiming device.Experienced g3 operator.Surgeons very dissatisfied, surgery time has increased.No optical changes can be seen on the aiming bracket and aiming sleeve.It had to be locked freehand and the complete nail had to be removed and replaced during the same operation.Device is in use for 6 years.Device has been reprocessed 80 times".

Manufacturer Narrative

The reported event could not be confirmed, since the returned device is conforming to specifications and is fully functional.The device inspection revealed the following: the received target device showed normal signs of usage evident by presence of scratches and other marks.No major damage could be observed which could affect the functionality of the device.However, significant hitting marks could be seen on the proximal part of the target device around the head region.A pre-surgical functional check was performed by assembling the returned target device and a sample nail and a sample drill to check the targeting accuracy.Upon assembly, functionality of the target device was fully given.There was no incidence of any drill contact with the nail around any of the holes in the nail.Thus, the alleged issue could not be reproduced and could not be confirmed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, since the device was found to be fully functional and working as intended, the issue is deemed to be user related.A proper functional check prior to the surgery is required as per ifu.Also as a secondary finding, it was communicated that the device has been in use for 6 years whereas the device was manufactured in the year 2022.So a discrepancy at the customer end may be there.If any additional information is provided, the investigation will be reassessed.

Event Description

As reported: "there was a misdrilling in the distal locking of the g3 nail using the aiming handle and aiming sleeve.Failed to place distal screw in g3 nail.Drills broke off 2x when trying to lock via aiming device.Experienced g3 operator.Surgeons very dissatisfied, surgery time has increased.No optical changes can be seen on the aiming bracket and aiming sleeve.It had to be locked freehand and the complete nail had to be removed and replaced during the same operation.Device is in use for 6 years.Device has been reprocessed 80 times.".

• Brand Name: TARGET DEVICE GAMMA3®
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 16639636
• MDR Text Key: 312412907
• Report Number: 0009610622-2023-00092
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: 04546540716774
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1320-0111
• Device Catalogue Number: 13200111
• Device Lot Number: KME817464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1