MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 6MM; BONE PLATE

Model Number	04.503.606.01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Date of infection is unknown.Implant date: unknown.Explant date: unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 a patient got an infection and had to do a wash out of mandible and removal of hardware.Surgeon believes patient co-morbidities may have caused the issue.Hardware removed after washout was complete and replaced with new hardware.This is report 3 of 6 for (b)(4).
Additional Manufacturer Narrative
The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental 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.
Additional Manufacturer Narrative
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 further reported that patient underwent initial implant surgery on (b)(6) 2017 and the hardware replacement took placed on (b)(6) 2018.
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.Customer quality conducted an investigation of the returned device.A screw was received at customer quality (cq) with allegation "no reported product problem".The screw was reported as part# 04.503.606.01 which is a 2.0mm titanium matrixmandible screw.There is no indication that this device was sold sterile to the customer, as the reported part# does not have an "s" suffix for "sterile" and no lot# exists on the screw and no lot# was provided by customer to confirm that it was sold as a sterile part in a sterile environment (sterile sealed pouch/bag).Any relevant diagnostic test to address the infection allegation could not be performed at cq because of the following.1.If the returned screw was sold sterile to the customer, the sterile environment in the sterile sealed bag no longer exists for analysis since the screw was received at cq loose in a non-sterile bag.2.The returned screw was decontaminated/processed through sterile processing at the hospital prior to shipping to synthes monument which would have removed any evidence of infectious causing matter.3.The returned screw was also decontaminated/processed through sterile processing at synthes monument facility prior to shipping to customer quality which would have removed any evidence of infectious causing matter.Therefore, this complaint for infection is not able to be confirmed.Whether this complaint can be replicated at customer quality cq is not applicable for this complaint condition.No new malfunctions were identified as a result of the investigation.A material test was not performed at cq on the returned device because there is no indication that material would cause an infection.A dimensional inspection was not performed at cq on the returned device because there is no indication that dimensions would cause an infection.A review of the device history records was unable to be performed since the lot number was unknown.Tabulated product drawing for the family of 2.0mm mandible self-tapping locking screws was reviewed during this investigation.No product design issues or discrepancies were observed.There is no allegation of device defect, deficiency or surgical technique error associated with this complaint.As there is no device malfunction alleged and no associated surgical technique error, a dcrm review will not be completed as it is outside of the scope of the dcrm.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Date returned to manufacturer 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: 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 6MM
• 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: 7286825
• Report Number: 2939274-2018-50704
• Device Sequence Number: 1210576
• Product Code: JEY
• UDI-Device Identifier: 10887587021829
• UDI-Public: (01)10887587021829(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K063790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/25/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.503.606.01
• Device Catalogue Number: 04.503.606.01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 02/14/2018; 03/15/2018; 04/06/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 03/13/2018; 03/22/2018; 04/27/2018
• 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