MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 30600090S

Device Problems Defective Device (2588); Positioning Problem (3009)

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

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device evaluated by mfr: device disposition is unknown.

Event Description

The following report was received from (b)(6): during the removal of a gamma nail long, used to reduce a multifragmented right femur fracture, distally and proximally blocked, the surgeon has noticed visible signs of rubbing of the cephalic screw on the nail in an abnormal location: out of the channel that normally houses the cephalic screw.The system is normally used percutaneously, so without a direct view of the operator but only via rx.The system is collimated by cannulas that allow this procedure.So customer reports that the incident is inexplicable except with an alleged defect in the instruments.Adverse event: asymmetry, lack of bone calcification.

Event Description

The following report was received from the italy competent authority org.(moh): during the removal of a gamma nail long, used to reduce a multifragmented right femur fracture, distally and proximally blocked, the surgeon has noticed visible signs of rubbing of the cephalic screw on the nail in an abnormal location: out of the channel that normally houses the cephalic screw.The system is normally used percutaneously, so without a direct view of the operator but only via rx.The system is collimated by cannulas that allow this procedure.So customer reports that the incident is inexplicable except with an alleged defect in the instruments.Adverse event: asymmetry, lack of bone calcification.

Manufacturer Narrative

The reported event could not be confirmed, 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.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.

• Brand Name: LAG SCREW, TI GAMMA3® Ø10.5X90MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8596809
• MDR Text Key: 144669856
• Report Number: 0009610622-2019-00242
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540374929
• UDI-Public: 04546540374929
• Combination Product (y/n): N
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 30600090S
• Device Lot Number: K0A172A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR