MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA 4X30MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-4030S
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2020
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 report.Device was discarded.
Event or Problem Description
As reported: "when the proximal target device was used, the drilling of the oblique hole went to the long direction, and the screw could not be inserted." additionally reported: "the screw was reported as the defective product".
Event or Problem Description
As reported: "when the proximal target device was used, the drilling of the oblique hole went to the long direction, and the screw could not be inserted." additionally reported: "the screw was reported as the defective product.".
Additional Manufacturer Narrative
The reported event that locking screw, fully threaded t2 tibia ø4x30mm was alleged of issue ¿implant - insertion impaired¿ could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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 manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The ifu clearly suggests: ¿before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on past complaint history some of the probable causes could be : improper preparation before use, surgeon not experienced with the use of target device, sleeves not fixed or not introduced far enough, load on instruments by soft tissue (incision not precise) etc.Which are all user related.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA 4X30MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9988796
• Report Number: 0009610622-2020-00159
• Device Sequence Number: 4597765
• Product Code: HSB
• UDI-Device Identifier: 04546540202345
• UDI-Public: 04546540202345
• Combination Product (Y/N): N
• PMA/510(K) Number: K003018
• 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): 06/05/2020

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: 06/30/2024
• Device Model Number: 1896-4030S
• Device Catalogue Number: 18964030S
• Device Lot Number: K08B05C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1