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

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2017

Event Type  malfunction  

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 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
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7151143
• MDR Text Key: 96168209
• Report Number: 2939274-2017-50424
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 10887587042176
• UDI-Public: (01)10887587042176(10)LOTUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400.054E
• Device Catalogue Number: 400.054E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23 YR