MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNPOR ORBITAL FLOOR PLATE 30MM/0.8MM THICK-STERILE; MESH,SURGICAL

Catalog Number 08.510.541S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: gwo, ftl.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is synthes sales consultant.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.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during an orbital repair to the eyelid, a synpor orbital floor plate was disintegrated upon insertion.Thus, the surgeon replaced the plate with a new one.There was a surgical delay of 5-10 minutes.The procedure was successfully completed with no adverse consequence to the patient.This report is for one (1) synpor orbital floor plate 30 mm/0.8 mm thick-sterile this is report 1 of 1 for complaint (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.Part 08.510.541s, lot ds7001864: manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: march 05, 2019.Expiry date: december 01, 2023.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was completed: the device was sent to the supplier for investigation.The device was analyzed to determine the composition of the material.The results were inconclusive, and the root cause cannot be determined.Relevant actions have been taken to address the issue.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.

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.E1: reporters state: (b)(6).H3, h4, h6: a review of the device history record has been requested.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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: SYNPOR ORBITAL FLOOR PLATE 30MM/0.8MM THICK-STERILE
• Type of Device: MESH,SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8777006
• MDR Text Key: 150674583
• Report Number: 8030965-2019-66128
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 07611819315914
• UDI-Public: (01)07611819315914
• Combination Product (y/n): N
• PMA/PMN Number: K051879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Catalogue Number: 08.510.541S
• Device Lot Number: DS7001864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Date Manufacturer Received: 09/11/2019
• Patient Sequence Number: 1
• Patient Age: 75 YR