MAUDE Adverse Event Report: SYNTHES MONUMENT SYNPOR SMOOTH ORBITAL FLOOR PLATE 24MM/0.8MM THK-STERILE; MESH, SURGICAL

Catalog Number 08.510.640S

Device Problems Break (1069); Flaked (1246)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Due to the intra-operative issue encountered, the plates are not considered to have been implanted or explanted.Per facility, the complainant parts were discarded and are no longer available for evaluation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: supplier: (b)(4) / packaged by: (b)(4), manufacturing date: december 21, 2015 ¿ expiration date: september 28, 2020.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Device 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 two (2) synpor smooth orbital floor plates (24mm and 35mm) were flaking and falling apart during an orbital floor fracture procedure on (b)(6) 2016.During the initial insertion attempt, the surgeon grasped the synpor floor plate with both hands and noted that the implant was flaking and falling apart into pieces.Insertion was then attempted with a second synpor floor plate, but the same issue occurred.All fragments were retrieved and the procedure was completed with a competitor's plate.No surgical delay was noted.It was noted that, prior to the procedure, the plates were stored on a shelf at room temperature.This report is 1 of 2 for (b)(4).

• Brand Name: SYNPOR SMOOTH ORBITAL FLOOR PLATE 24MM/0.8MM THK-STERILE
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5755232
• MDR Text Key: 49279135
• Report Number: 1719045-2016-10517
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2020
• Device Catalogue Number: 08.510.640S
• Device Lot Number: DSD0459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1