MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXMIDFACE SCREWDRIVER BLD W/SPRG HLDG SLV LONG/95MM HXC; SCREWDRIVERS

Model Number	03.503.206
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not expected to be returned for manufacturer review/investigation.(b)(4).Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on an unknown date in (b)(6) 2018, patient was implanted with three mandible plates.One of the three plates implanted became infected, and patient wished for them to be removed.On an unknown date, patient underwent hardware removal procedure.During the removal surgery, surgeon noted that during the initial implant procedure, an older systems instead of latest matrix line was used.As per the surgeon, this is a public safety issue as not all hospitals in the area have the older set available.Synthes craniofacial modular fixation system & mandible modular fixation system were used to initially place the implants.During the removal surgery, surgeon had the universal screw removal set, as well as a matrixmandible screwdriver at his disposal.The unknown screw was stripped.He claims the provided drivers, and blades were not the appropriate instruments, and does not believe the it should be allowed to use an older system, when it is not readily available to all local hospitals.It was further reported that there was no allegation or malfunction with the screws were mentioned, just that the proper screwdriver blade was not available, making their removal more difficult.There was a surgical delay of four (4) hours and patient was under anesthesia for the duration of the case.Procedure was completed successfully.Patient outcome was unknown.This (b)(4) captures the intra-operative event during removal surgery, while (b)(4) captures the post-operative infection and required removal.This report is for one (1) matrixmidface screwdriver.This is report 1 of 5 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.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
Further it was reported that the patient underwent hardware removal surgery on (b)(6) 2019.
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.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
There was a surgical delay of three (3) hours and patient was under anesthesia for the duration of the case.Procedure was successfully completed.

• Brand Name: MATRIXMIDFACE SCREWDRIVER BLD W/SPRG HLDG SLV LONG/95MM HXC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8433599
• Report Number: 2939274-2019-57023
• Device Sequence Number: 19098240
• Product Code: HXX
• UDI-Device Identifier: 10887587012544
• UDI-Public: (01)10887587012544
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.503.206
• Device Catalogue Number: 03.503.206
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 04/17/2019; 04/19/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 04/18/2019; 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR