MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNPOR SMOOTH ORBITAL FLOOR PLATE 24MM/0.8MM THK-STERILE; MESH,SURGICAL

Model Number	08.510.640S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: gwo, ftl.Complainant part is not expected to be returned for manufacturer review/investigation.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 or Problem Description
It was reported that during an unknown procedure on an unknown date, the film from polyethylene implant that was supposed to be on top of the synpor smooth orbital floor plate was delaminated and peeling off.The procedure was successfully completed with the use of another implant.There was no surgical delay, and no patient consequence reported.This report is for one (1) synpor smooth orbital floor plate 24mm/0.8mm thk-sterile.This is report 1 of 1 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.H4, h6: a device history record (dhr) review was conducted: manufacturing location: - supplier ¿ dsm biomedical-kensey nash / inspected and released by: monument, release to warehouse date: 31-jan-2018, expiration date: 28-jul-2022.Part number: 08.510.640s, synpor smooth orbital floor plate 24mm / 0.8mm thk¿ sterile, lot number: dse5437 (sterile), lot quantity: 111.One piece was scrapped in cell, incoming final inspection, as a destructive test.Purchased finished goods traveler met all inspection acceptance criteria apart from the one piece noted.Note: due to the destructive nature of inspection (sterile packaged), only one piece is physically inspected per lot.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of conformance supplied by dsm biomedical dated 28-sep-2017 was reviewed and determined to be conforming.Sterile product release checklist supplied by dsm biomedical dated 28-sep-2017 was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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: SYNPOR SMOOTH ORBITAL FLOOR PLATE 24MM/0.8MM THK-STERILE
• Common Device Name: MESH,SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10645362
• Report Number: 2939274-2020-04569
• Device Sequence Number: 16782976
• Product Code: FTM
• UDI-Device Identifier: 10887587026244
• UDI-Public: (01)10887587026244
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K051879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2022
• Device Model Number: 08.510.640S
• Device Catalogue Number: 08.510.640S
• Device Lot Number: DSE5437
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 11/02/2020
• Patient Sequence Number: 1