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

Catalog Number 30600085S

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Fall (1848)

Event Date 09/10/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that patient's femur was revised after patient fell and lag screw went through the femoral head.

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 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
• 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: 7923910
• MDR Text Key: 122295829
• Report Number: 0009610622-2018-01339
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540374912
• UDI-Public: 04546540374912
• 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: 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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 30600085S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 10/01/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 95 YR