MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM; BONE PLATE

Model Number	400.834E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number not available for reporting.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes sales representative.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 on an unknown date, a patient underwent a craniotomy tumor resection.As the surgeon was implanting the three (3) ti low profile neuro screw self-drilling, the screw heads came off and the remaining portion of the screws remained in the patient.Surgical procedure and patient outcome are unknown.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
The incorrect date was inadvertently utilized in initial medwatch.The correct date is (b)(6) 2018.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: TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM
• 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: 7878209
• Report Number: 2939274-2018-53774
• Device Sequence Number: 19387541
• Product Code: JEY
• UDI-Device Identifier: 10887587045429
• UDI-Public: (01)10887587045429
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K022012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2018

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: 400.834E
• Device Catalogue Number: 400.834E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 10/22/2018; 10/22/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/22/2018; 10/22/2018
• Patient Sequence Number: 1