MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE; BONE PLATE

Model Number	805.604.02S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient underwent orif of frontal sinus fracture.During the surgery, the screw head was broken while the surgeon was inserting the resorbable screw.The broken part of the screw is remains in the patient.The surgery was completed successfully.The patient outcome was unknown.This complaint involves one (1) device.This report is for (1) 1.5mm rapid resorbable cortex screw 4mm-sterile this report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
(b)(4) additional narrative: complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot part: 805.604.02s lot: 7l03955 manufacturing site: (b)(4) release to warehouse date: july 16, 2020 expiration date: june 01, 2023.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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.

• Brand Name: 1.5MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE
• Common Device Name: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12572337
• Report Number: 2939274-2021-05903
• Device Sequence Number: 3686784
• Product Code: JEY
• UDI-Device Identifier: 20887587061655
• UDI-Public: 20887587061655
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K062789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2021

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: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: 805.604.02S
• Device Catalogue Number: 805.604.02S
• Device Lot Number: 7L03955
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 10/04/2021
• Patient Sequence Number: 1