MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0 TI MATRIXMANDIBLE SCREW STPING 8; SCREW, FIXATION, BONE

Model Number	04.503.408.01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Of the 1 devices reported 0 devices were received for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
This report summarizes 1 malfunction events involving a total of 1 actual devices for broken screws.

• Brand Name: 2.0 TI MATRIXMANDIBLE SCREW STPING 8
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12242295
• Report Number: 2939274-2021-04302
• Device Sequence Number: 3635784
• Product Code: HWC
• UDI-Device Identifier: 10887587020532
• UDI-Public: 10887587020532
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.503.408.01
• Device Catalogue Number: 04.503.408.01
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 07/28/2021
• Patient Sequence Number: 1