MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965050S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that on (b)(6) 2015, t2gtn was implanted in the left femur.The nail was revised to t2f at (b)(6) 2019, because the nail was fractured after deployed it and the patient had bone metastasis.Additional information received indicated that the two screws at distal part were broken nail was not broken.
Event or Problem Description
It was reported that on (b)(6) 2015, t2gtn was implanted in the left femur.The nail was revised to a t2 on (b)(6) 2019, because the nail was fractured after deployed it and the patient had bone metastasis.Additional information received indicated that the two screws at distal part were broken.Nail was not broken.
Additional Manufacturer Narrative
The reported event that locking screw, fully threaded t2 tibia ø5x50 mm was alleged to be broken was confirmed, since the device was returned for evaluation and matches the alleged failure mode.Visual inspection of the returned product was performed, and the reported locking screw was found to be completely broken approx.Distal into two fragments each.All breakage surfaces of broken fragments show features of a fatigue fracture such as smooth topography and lines of rest.Plastic deformation was not found.The thread flanks of the locking screw are significantly flattened.Damage found at the threads of the screw such as friction signs resp.Bearing points indicate high axial load application.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a patient related issue.The damage of the reported locking screw was most likely caused as a result of a fatigue fracture caused by repeated overloading during the implantation period.Overload may have been caused by patient¿s load application possibly in conjunction with impaired bone healing.Review of complaint history, capa databases, risk analysis and labelling did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.If any further information is provided, the complaint report will be updated.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM
• 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: 8374918
• Report Number: 0009610622-2019-00084
• Device Sequence Number: 16664560
• Product Code: HSB
• UDI-Device Identifier: 04546540202512
• UDI-Public: 04546540202512
• Combination Product (Y/N): N
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 18965050S
• Device Lot Number: K0E67CA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/22/2019
• 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 Age: 65 YR
• Patient Weight: 80