MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X75 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5075S
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental.Device not available to stryker.
Event or Problem Description
This report is out of box failure.The physician noticed that there was powder of cushioning on the screw.The physician considered it can not be used, and changed to the other device.The procedure was completed using other device.
Event or Problem Description
This report is out of box failure.The physician noticed that there was powder of cushioning on the screw.The physician considered it can not be used, and changed to the other device.The procedure was completed using other device.
Additional Manufacturer Narrative
Evaluation revealed the packaging of the locking screw, fully threaded t2 tibia ø5x75 mm to be the subject product.No further associated products were reported.The device resp.Packaging reported was not returned to stryker kiel and thus, a physical examination of the subject device was impossible.Below report is based on available information, only.Review of the manufacturing documents revealed no discrepancies; the item was documented as faultless prior to distribution.Based on the information given an exact root cause could not be determined.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.No non-conformity was identified.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X75 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: 7410159
• Report Number: 0009610622-2018-00173
• Device Sequence Number: 10775376
• Product Code: HSB
• UDI-Device Identifier: 04546540202567
• UDI-Public: (01)04546540202567
• Combination Product (Y/N): N
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 1896-5075S
• Device Catalogue Number: 18965075S
• Device Lot Number: K0B625E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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: Other