MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X80MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 30600080S

Device Problems Failure to Osseointegrate (1863); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Hospital retained.

Event Description

It was reported that the patient's right femur was revised due to failed fixation of the short gamma nail.Patient was revised to a stryker hemi hip construct.Rep reported that he can provide an x-ray and confirmed that no further information is available.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and only an x-ray was shared by the customer.With the available medical information and the x-ray provided, a medical opinion was sought from the medical expert, but no conclusive statement or opinion could be made due to insufficient information.More detailed information about the complaint event as well as the affected device, pre-operative x-ray, post-operative x-ray and patient¿s medical records must be available in order to determine the root cause of the complaint event.The probable root cause of the complaint event could be due to poor positioning of the lag screw and the patient factor.The provided lot number is incorrect; therefore a review of the device history could not be performed.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that the patient's right femur was revised due to failed fixation of the short gamma nail.Patient was revised to a stryker hemi hip construct.Rep reported that he can provide an x-ray and confirmed that no further information is available.

• Brand Name: LAG SCREW, TI GAMMA3® Ø10.5X80MM
• 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: 9258555
• MDR Text Key: 170519584
• Report Number: 0009610622-2019-00906
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540374905
• UDI-Public: 04546540374905
• 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: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 30600080S
• Device Lot Number: K0A3013D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Weight: 54