MAUDE Adverse Event Report: SYNTHES USA MESH,SURGICAL

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: (b)(6). Date device malfunctioned is unknown. This report is for one (1) unknown matrixmidface synpor porous polyethylene plate. Part and lot number is unknown. Without the valid part and lot number, the udi is not available. Implant date: unknown. (therapy date): unknown without a lot number, the device history record review could not be requested. The (510k): unknown the device has been received and the product evaluation is in progress. No conclusion can be drawn. 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 report that the patient had original surgery on unknown date for an orbital floor fracture. Patient was implanted with one (1) synpor porous polyethylene plate implant and two (2) mid-face self-drilling screws. On an unknown post-operative date, the synpor coating became detached from the plate. On (b)(6) 2017 the surgeon removed all implants and revised the patient to a resorbable floor plate and screws. It was reported that no fragments were generated during implant removal, and all explanted devices were intact. Revision surgery was completed successfully with no time delay. Patient is reported in stable condition. Concomitant devices reported: midface self-drilling screws (part # unknown, lot # unknown, qty 2). This report is for one (1) unknown matrixmidface synpor porous polyethylene plate. This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Patient code (b)(4) is utilized as the device fell apart and required a revision to remove and replace it. 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

Product development investigation was completed. A visual inspection under 5x magnification and drawing review were performed as part of this investigation. This complaint is confirmed. The polyethylene coating was returned separate from the plate in the bag. One fixation hole portion of the plate was broken off. However, per the complaint description "all explanted devices were intact", therefore it is determined that the plate broke during subsequent handling at decontamination at hospital or monument. Based on the purple color and remaining geometry of the returned implant, it is determined that it is a synpor implant titanium reinforced fan plate. It could not be determined whether the plate had exposed fixation holes or not. The returned device is an implant available for use in the synpor porous polyethylene implants system for craniofacial and orbital augmentation and reconstruction per technique guide. Tabulated drawing for the family of porous/smooth polyethylene sheets with titanium mesh 0. 8mm thick plates was reviewed during this investigation. No product design issues or discrepancies were observed. No definitive root cause could be determined. It was determined that the malfunction may have occurred most likely due to excessively contouring implant during contouring/handling/ implantation causing partial delamination which was not identified during surgery. 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.

• Type of Device: MESH,SURGICAL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6527318
• MDR Text Key: 73892937
• Report Number: 2520274-2017-11537
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/27/2017 Patient Sequence Number: 1