MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X35 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965035S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2019
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 remains implanted.
Event or Problem Description
It was reported that when the drill was inserted to distal screw hole of gamma nail through the target device, the drill was hit to the screw hall nail but the surgeon continued to drill and screw was implanted.After that, the surgeon confirmed that the screw was backed out but the screw was implanted because it was stuck and the operation was finished.
Event or Problem Description
It was reported that when the drill was inserted to distal screw hole of gamma nail through the target device, the drill was hit to the screw hall nail but the surgeon continued to drill and screw was implanted.After that, the surgeon confirmed that the screw was backed out but the screw was implanted because it was stuck and the operation was finished.
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.More information as well as product must be available for determining the exact root cause of the failure.However, the event suggests that there was a case of mis-drilling, so one of the possible causes can be the slight shifting of hole location which in turn didn¿t match adequately with the screw upon insertion.This mismatch could have led to inadequate screwing due to lack of grip inside.Subsequently, the screw backed out a little.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.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 Ø5X35 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: 9073105
• Report Number: 0009610622-2019-00697
• Device Sequence Number: 16768846
• Product Code: HSB
• UDI-Device Identifier: 04546540202482
• UDI-Public: 04546540202482
• 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): 10/29/2019

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: 03/31/2024
• Device Catalogue Number: 18965035S
• Device Lot Number: K03D079
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1