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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM RAPID RESORBABLE CORTEX SCREW 3MM-STERILE; BONE PLATE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM RAPID RESORBABLE CORTEX SCREW 3MM-STERILE; BONE PLATE Back to Search Results
Model Number 805.603.04S
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 4 of 8 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.
 
Event Description
This is report 4 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.
 
Event Description
This report is for a 1.5mm rapid resorbable cortex screw 3mm-sterile.
 
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Brand Name
1.5MM RAPID RESORBABLE CORTEX SCREW 3MM-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 Key8757862
MDR Text Key149935100
Report Number2939274-2019-59004
Device Sequence Number1
Product Code JEY
UDI-Device Identifier20887587061624
UDI-Public(01)20887587061624
Combination Product (y/n)N
PMA/PMN Number
K062789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2019
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Model Number805.603.04S
Device Catalogue Number805.603.04S
Was Device Available for Evaluation? No
Date Manufacturer Received07/03/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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