MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM RAPID RESORBABLE CORTEX SCREW 3MM-STERILE; BONE PLATE

Model Number	805.603.10S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(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) 2019, there was a rapidsorb mesh plate exposure under surgical suture site, patient allergic reaction to the material, and break down of skin.The following devices were implanted on (b)(6) 2018: one (1) rapid resorb straight row mesh, one (1) 1.5 rapid resorbable cortex screw 3 mm sterile, one (1) 1.5 rapid resorbable cortex screw 6 mm sterile, two (2) 1.5 rapid resorbable cortex screw 3 mm sterile, one (1) 1.5 rapid resorbable cortex screw 4 mm sterile, one (1) 1.5 rapid resorbable cortex screw 4 mm sterile hexagonal coupling, one (1) 1.5 rapid resorbable cortex screw 6 mm sterile hexagonal coupling.The devices have not been explanted.Wound area is being managed and no revision or second surgery has been planned.Patient status is unknown.This report is for a 1.5 mm rapid resorbable cortex screw 3 mm-sterile.This is report 5 of 8 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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
This is report 5 of 6 for (b)(4).

• Brand Name: 1.5MM RAPID RESORBABLE CORTEX SCREW 3MM-STERILE
• 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: 8758062
• Report Number: 2939274-2019-59006
• Device Sequence Number: 11380936
• Product Code: JEY
• UDI-Device Identifier: 20887587061631
• UDI-Public: (01)20887587061631
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K062789
• 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
• Report Date (Section B): 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 805.603.10S
• Device Catalogue Number: 805.603.10S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 07/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention