MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 1.5MM TI CORTEX SCR SLF-DRLG WITH PLUSDRIVE(TM) RECESS 4MM; SCREW FIXATION INTRAOSSEOUS

Model Number	400.054E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight is unknown.Device broke intra-operatively; device not considered implanted/explanted.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.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 lefort1/ bilateral sagittal split osteotomy (bsso) procedure, while using a ball point driver (bpd) screwdriver to insert a 1.5 mm self-drilling screw into the maxilla, the screw head separated from the stem of the screw.The stem of the screw remains intact in the patient.There was no apparent harm to the patient and no delay in the case.The head of the screw could not be found at the time.Concomitant device(s) reported: screwdriver blade (part 313.252, lot unknown, quantity 1); battery powered driver (part 05.000.008, lot unknown, quantity 1); sterile battery (part 05.000.007.01s, lot unknown, quantity 1).(b)(4).

• Brand Name: 1.5MM TI CORTEX SCR SLF-DRLG WITH PLUSDRIVE(TM) RECESS 4MM
• 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: 7151143
• Report Number: 2939274-2017-50424
• Device Sequence Number: 854503
• Product Code: DZL
• UDI-Device Identifier: 10887587042176
• UDI-Public: (01)10887587042176(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K963546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2017

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: 400.054E
• Device Catalogue Number: 400.054E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR