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

Catalog Number	30600080S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Hospital retained.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0009610622-2019-00906
• Device Sequence Number: 11384288
• Product Code: HSB
• UDI-Device Identifier: 04546540374905
• UDI-Public: 04546540374905
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 30600080S
• Device Lot Number: K0A3013D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 54