MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM RAPID RESORBABLE CORTEX SCREW 6MM-STERILE; BONE PLATE

Model Number 805.606.04S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076); No Code Available (3191)

Event Type  Injury  

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 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 6 mm-sterile.This is report 3 of 8 for (b)(4).

Event Description

This is report 3 of 6 for (b)(4).

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: 1.5MM RAPID RESORBABLE CORTEX SCREW 6MM-STERILE
• Type of Device: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8757762
• MDR Text Key: 149933442
• Report Number: 2939274-2019-59003
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 20887587061730
• UDI-Public: (01)20887587061730
• Combination Product (y/n): N
• PMA/PMN Number: K062789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 805.606.04S
• Device Catalogue Number: 805.606.04S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 07/03/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention