MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X85MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30600085S
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Hospital retained.
Event or Problem Description
It was reported that patient's femur was revised after patient fell and lag screw went through the femoral head.
Additional Manufacturer Narrative
The reported event that lag screw, ti gamma3® ø10.5x85mm was alleged of ' implant - dislocated' could be confirmed (consulting the x-ray).Based on investigation, the root cause was attributed to be patient related.The failure was caused after patient fell and lag screw went through the femoral head.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.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 patient's femur was revised after patient fell and lag screw went through the femoral head.

• Brand Name: LAG SCREW, TI GAMMA3® Ø10.5X85MM
• 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: 7923910
• Report Number: 0009610622-2018-01339
• Device Sequence Number: 1936290
• Product Code: HSB
• UDI-Device Identifier: 04546540374912
• UDI-Public: 04546540374912
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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: 30600085S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 11/09/2018
• 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