MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM IMF SCREW SELF-DRILLING 8MM; SCREW FIXATION INTRAOSSEOUS

Model Number	201.928
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 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
It was reported that on (b)(6) 2019, during dental surgery and intramaxillary fixation, three (3) intramaxillary fixation screws broke.The patient had a mandible fracture.The screws were removed.There was a surgical delay of twenty (20) minutes.Procedure outcome was unknown.There was no patient consequence.Concomitant devices reported: unknown precut cerclage wires (part# unknown, lot# unknown, quantity: unknown).This is report 1 of 3 for (b)(4).

• Brand Name: 2.0MM IMF SCREW SELF-DRILLING 8MM
• Common Device Name: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8679615
• Report Number: 2939274-2019-58540
• Device Sequence Number: 1935969
• Product Code: DZL
• UDI-Device Identifier: 20887587028634
• UDI-Public: (01)20887587028634
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K010527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2019

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 Model Number: 201.928
• Device Catalogue Number: 201.928
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 06/07/2019
• Patient Sequence Number: 1