MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 20MM; PLATE, FIXATION, BONE

Model Number	201.370.97
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Irritation (2076)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s height reported as 5 feet 5 inches.Device remains implanted; as such explant date is not applicable.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.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 that on (b)(6) 2018, patient underwent (orif) open reduction internal fixation using synthes rapid absorbing plate system, due to comminuted tripod fracture of left zygomaticomaxillary complex (zmc).The 1.5mm rapid resorbable orbital rim plate, 2.0mm rapid resorbable y-plate, two (2) 1.5mm rapid resorbable cortex screw, two (2) 2.0mm rapid resorbable cortex screw, and one (1) 2.0mm cortex screw slf-tpng with stardrive recess was implanted during a left (zygomaticomaxillary complex zmc) fracture repair.After six months, patient was complaining of tenderness and slightly palpable at the surgery site.Initial procedure was completed successfully without any issues.Patient was stable after the procedure.This report is for one (1) 2.0mm cortex screw self-tapping with stardrive recess 20mm.This is report 6 of 7 for complaint (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
1/4/2019.Updated event description: it was reported that the patient originally underwent (orif) open reduction internal fixation using synthes rapid absorbing plate system due to comminuted tripod fracture on (b)(6) 2018.The 1.5mm rapid resorbable orbital rim plate, 2.0mm rapid resorbable y-plate, two (2) 1.5mm rapid resorbable cortex screw, two (2) 2.0mm rapid resorbable cortex screw, and 2.0mm cortex screw slf-tpng with stardrive recess was implanted during a left (zygomaticomaxillary complex zmc) fracture repair.After six months, patient was complaining of tenderness and slightly palpable at the surgery site.No revision surgery will be performed.This complaint involves seven (7) devices.
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.

• Brand Name: 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 20MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8108226
• Report Number: 2939274-2018-55123
• Device Sequence Number: 13943274
• Product Code: HRS
• UDI-Device Identifier: 10886982141934
• UDI-Public: (01)10886982141934
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K063049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2018

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: 201.370.97
• Device Catalogue Number: 201.370.97
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 01/04/2019; 01/04/2019
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 01/04/2019; 01/04/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Weight: 58