MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3® 300X160MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1320-0111

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Primary gamma nail procedure.It was reported that outside of the patient, the targeter aligned to the dummy short gamma nail.In the patient, the targeter would not align for the distal screw on the short gamma nail.The case was converted to a long gamma nail so that the screws could be placed manually.Surgery was completed successfully with a delay of approximately 15 minutes.The wasted nail and targeter are allegedly available for return.

Event Description

Primary gamma nail procedure.It was reported that outside of the patient, the targeter aligned to the dummy short gamma nail.In the patient, the targeter would not align for the distal screw on the short gamma nail.The case was converted to a long gamma nail so that the screws could be placed manually.Surgery was completed successfully with a delay of approximately 15 minutes.The wasted nail and targeter are allegedly available for return.

Manufacturer Narrative

The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: reveals no significant damage to devices.Functional inspection: devices were tested in complete assembly with the following: drill, drill sleeve, tissue protection sleeve, speedlock sleeve gamma 3 and gamma 3 nail ¿ 180mm.Devices were successfully assembled and drill bit seamlessly fit through all components as required and described in the optech without misalignment.Dimensional inspection: due to the nature of the complaint, a dimensional inspection was not considered necessary.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 investigation, the root cause was attributed to a user related issue.The failure was caused by inadequate assembly of required devices.If any further information is provided, the complaint report will be updated.

• Brand Name: TARGET DEVICE GAMMA3® 300X160MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9513720
• MDR Text Key: 178745918
• Report Number: 0009610622-2019-00985
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: 04546540716774
• Combination Product (y/n): N
• PMA/PMN Number: K123401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

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
• Device Operator: Health Professional
• Device Model Number: 1320-0111
• Device Catalogue Number: 13200100
• Device Lot Number: KP237385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Initial Date Manufacturer Received: 12/01/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1