MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/6MM LENGTH; BONE PLATE

Model Number	04.503.824.01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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) 2019, during an open reduction internal fixation (orif) of the mandible fracture, the matrixwave titanium screw self-drilling was inserted for temporary fixation and as the surgeon was backing out the screw it broke in half midway up the shaft.Fragments were generated but it was not removed easily.The broken screw shaft was virtually flush with bone and was left in the patient's bone.There was no surgical delay.Procedure was successfully completed.Patient outcome is unknown.This report is for one (1) matrixwave mmf ti 1.85mm screw self-drilling/6mm length.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: a product investigation was conducted.Visual inspection: the matrixwave mmf ti 1.85 mm screw self-drilling/ 6 mm length (part # 04.503.824.01, lot # unknown) was received at us cq with the distal portion of the device broken off and not returned to us cq.According to the complaint the distal portion of the device is embedded in the patient.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection: dimensional analysis was completed, the length of the screw measured and approximately 4.81 mm of the device broke off per relevant drawings.No relevant dimensions could be measured due to post-manufacturing damage.Document/specification review: the relevant drawing(s) was reviewed; a dhr review could not be performed as the lot number is unknown.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/6MM 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: 8536461
• Report Number: 2939274-2019-57589
• Device Sequence Number: 16754999
• Product Code: JEY
• UDI-Device Identifier: 10887587069470
• UDI-Public: (01)10887587069470
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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: 04.503.824.01
• Device Catalogue Number: 04.503.824.01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 05/24/2019
• Patient Sequence Number: 1
• Patient Age: 41 YR