MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/8MM LENGTH; BONE PLATE

Model Number	04.503.825.01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Lot number is unknown.Device malfunctioned intra-operatively and was not 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.(b)(4).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 (b)(6) 2018, the surgeon performed an unknown procedure and the matrix wave screw broke off during implantation.The broken shaft of the screw was removed.There was a surgical delay of 15 minutes.It was unknown if there was a patient consequence.No procedure outcome reported.This report is for a matrixwave mmf ti 1.85mm screw self-drilling/8mm length.This is report 1 of 1 for (b)(4).

• Brand Name: MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/8MM LENGTH
• 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: 7553680
• Report Number: 2939274-2018-52338
• Device Sequence Number: 176903
• Product Code: JEY
• UDI-Device Identifier: 10887587069487
• UDI-Public: (01)10887587069487
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141165
• 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): 05/09/2018

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: 04.503.825.01
• Device Catalogue Number: 04.503.825.01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1