MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREW,AXS,SD,1.7X6MM,5P; IMPLANT

Model Number	56-17906
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during the procedure, the saw blade caught in the guide resulting in a vibration.The vibration caused the fixation screws to release and two of the screws came out of the surgical site, posing the risk of a material being lost in a surgical site.One screw was located in the oral cavity and the other screw was located post operatively when the draping was removed.The procedure was completed successfully.There was no clinically significant delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
The customer reported that during the procedure, the saw blade caught in the guide resulting in a vibration.The vibration caused the fixation screws to release and two of the screws came out of the surgical site, posing the risk of a material being lost in a surgical site.One screw was located in the oral cavity and the other screw was located post operatively when the draping was removed.The procedure was completed successfully.There was no clinically significant delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Based on statistical evaluation, there are no indications for any design, material or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.If further information becomes available, the investigation will be re-evaluated.

• Brand Name: BONE SCREW,AXS,SD,1.7X6MM,5P
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 16454690
• Report Number: 0008010177-2023-00011
• Device Sequence Number: 2343794
• Product Code: JEY
• UDI-Device Identifier: 37613327358385
• UDI-Public: 37613327358385
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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 Model Number: 56-17906
• Device Catalogue Number: 56-17906
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown