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

Model Number	04.503.104.20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: (b)(6).(b)(4).Due to intra-operative issues, the device was not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation, as it was reportedly discarded.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 the heads of two (2) matrixneuro screws broke off during a synthetic cranioplasty procedure on (b)(6) 2017.The surgeon was inserting the screws into a patient specific peek implant (psi) when the tips of two of the screws broke off.Fragments were generated in the patient but were all removed, except for the tip of one of the screws that remained in the implant.The piece that remained was burred down until it was flush with the implant.The surgery was completed successfully.There was no reported patient consequence.There was no reported surgical delay.(b)(4).

• Brand Name: TI MATRIXNEURO 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: 7122007
• Report Number: 2939274-2017-50308
• Device Sequence Number: 13902847
• Product Code: JEY
• UDI-Device Identifier: 20887587018345
• UDI-Public: (01)20887587018345(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K123723
• 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): 11/16/2017

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: 04.503.104.20
• Device Catalogue Number: 04.503.104.20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 66