MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X60 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5060S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2020
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: "the locking screw was unable to be inserted.The drill diameter was also checked and digging the target site again, but it was still unable to be inserted.Since it was forcefully attempted to insert, the screw was shaped (broken).The screw was then replaced with new one but the same event occurred.The surgeon stated that the event occurred due to bone quality (hard bone).".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.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.A review of the labeling did not indicate any abnormalities.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, as per the event stated, the most likely cause of breakage would be, but not limited to: improper drilling due to a hard bone forcing the user to apply high forces leading to its fracture.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the locking screw was unable to be inserted.The drill diameter was also checked and digging the target site again, but it was still unable to be inserted.Since it was forcefully attempted to insert, the screw was shaped (broken).The screw was then replaced with new one but the same event occurred.The surgeon stated that the event occurred due to bone quality (hard bone).".

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X60 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; DE D-24232
• MDR Report Key: 9960738
• Report Number: 0009610622-2020-00149
• Device Sequence Number: 11371941
• Product Code: HSB
• UDI-Device Identifier: 04546540202536
• UDI-Public: 04546540202536
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2020

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: 09/30/2024
• Device Model Number: 1896-5060S
• Device Catalogue Number: 18965060S
• Device Lot Number: K0471BF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1