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

Model Number 805.606.02S

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

Patient Problems Reaction (2414); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

It was reported that the patient underwent removal of plate on (b)(6) 2019, due to the patient reaction of implanted material.The patient reactions included redness and swelling that led to drainage at the surgical site on the left side of the patients head.The patient was originally implanted on an unknown date with the following devices; one (1) rapid resorb straight row mesh-sterile, one (1) rapidsorb cortex screw, three (3) 1.5 mm cortex screw, two (2) 1.5 mm cortex screw.Patient bone had fused.There was no surgical delay.Hardware removal was completed successfully.Patient outcome is unknown.This is report 3 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.Implant date unknown date in (b)(6) 2018.Device history review, part: 805.606.02s, lot: l653417, manufacturing site: oberdorf, release to warehouse date: 14.Dec.2017 , expiry date: 31.Oct.2021.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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

Updated: the original surgery date was on an unknown date in (b)(6) 2018.

• 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: 8767164
• MDR Text Key: 150251713
• Report Number: 2939274-2019-59042
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 20887587061723
• UDI-Public: (01)20887587061723
• 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: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 805.606.02S
• Device Catalogue Number: 805.606.02S
• Device Lot Number: L653417
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention