MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LOW PROFILE NEURO SCREW SELF-DRILLING 5MM; BONE PLATE

Model Number	400.835E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight not available for reporting.Device malfunctioned intra-operatively, only the broken screw shaft remains implanted/embedded.The screw head was retrieved.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 patient underwent a craniotomy for bone flap replacement on an unknown date.During the procedure, while three (3) of the low profile neuro screws were being implanted, the head of the screw broke off.The screw shaft remains embedded in the patient¿s bone.It is unknown if procedure was delayed due to the device breakage.This report is for one (1) low profile neuro screw.This is report 3 of 3 for (b)(4).

• Brand Name: TI LOW PROFILE NEURO SCREW SELF-DRILLING 5MM
• 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: 7904387
• Report Number: 2939274-2018-53936
• Device Sequence Number: 16492581
• Product Code: JEY
• UDI-Device Identifier: 10887587045450
• UDI-Public: (01)10887587045450
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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: 400.835E
• Device Catalogue Number: 400.835E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/24/2018
• Patient Sequence Number: 1