MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADVANCED LOCKING SCREW IMN SCREWS 5X50MM; SCREW, FIXATION, BONE

Model Number	2361-5050S
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
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 in patient.
Event or Problem Description
As reported: "the initial operation for tibial trunk surgery was performed on (b)(6) 2020.Since t2 alpha advanced locking screw was coming off (since unknown date).The patient was causing the infection, and there may be some causal relationship.".
Event or Problem Description
As reported: "the initial operation for tibial trunk surgery was performed on (b)(6) 2020.Since t2 alpha advanced locking screw was coming off (since unknown date).The patient was causing the infection, and there may be some causal relationship.".
Additional Manufacturer Narrative
The reported event could be confirmed, since provided x-ray image shows the dislocated screw which was confirmed by a hcp as well.A device inspection was impossible due to missing implant [still implanted] and a review of the dhr revealed no discrepancies, in particular for the sterilization steps performed.According to further details received ¿surgeon not willing to disclose any information¿ evaluation was limited to information provided within product inquiry, only.Finally, according to further information received after the completion of the primary investigation, the type of microorganism is unknown and thus a complementary medical statement is impossible.Based on investigation it could not be excluded that the reported event is related to the infection and thus, it has to be classified as patient-patient factors issue.In case the item and / or substantive information will become available in future that suggests otherwise; the file will be reviewed.

• Brand Name: ADVANCED LOCKING SCREW IMN SCREWS 5X50MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11346641
• Report Number: 0009610622-2021-00285
• Device Sequence Number: 16791870
• Product Code: HWC
• UDI-Device Identifier: 07613327381559
• UDI-Public: 07613327381559
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• 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): 04/02/2021

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: Lay User/Patient
• Device Model Number: 2361-5050S
• Device Catalogue Number: 23615050S
• Device Lot Number: K04164A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR