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

Model Number	201.928E
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: patient¿s gender and weight are unknown.Due to the intra-operative events, the device was not successfully implanted.As such, implant/explant dates are not applicable.Complainant device is not expected to be returned for manufacturer review/investigation.Reporter phone number is not provided for reporting.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during a procedure on (b)(6) 2017 a 2.0 mm imf screw self drilling 8 mm broke when the surgeon was trying to insert it in the mandible of the patient.The broken fragment was removed and the surgery was completed without any delay.The patient was stable after the surgery.Concomitant device reported: screwdriver (part # unknown, lot # unknown qty # unknown).This report is for one (1) 2.0mm imf screw self-drilling 8mm.(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: 7139095
• Report Number: 2939274-2017-50397
• Device Sequence Number: 16512030
• Product Code: DZL
• UDI-Device Identifier: 10887587028644
• UDI-Public: (01)10887587028644(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2017

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: 201.928E
• Device Catalogue Number: 201.928E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR