MAUDE Adverse Event Report: SYNTHES MONUMENT SYNPOR SMOOTH TI REINFORCED FAN PL FIXTN H/0.8MM THK-STER; PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE

Catalog Number 08.520.221S

Device Problem Peeled/Delaminated (1454)

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

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

Patient id: (b)(6).Patient weight is unknown.Additional product code: ftl and ftm.Other: (b)(4).Device was not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Part number: 08.520.221s, lot number: dsd0059: release to warehouse date: 20october2015.Expiration date: 28july2020.Manufacturing site is (b)(4) and supplied by (b)(4).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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during open reduction and internal fixation (orif) orbital fracture repair surgery two of the synpor smooth titanium reinforced fan plates delaminated before implanting them.Surgeon opened the first synpor smooth titanium reinforced fan plates and that delaminated.Then he opened the second one and that also delaminated.Then they opened the third one and that worked.No fragments remained in the patient.There was ten (10) minute surgical delay due to the reported event.Surgery was completed successfully without any further medical intervention required and without any harm to the patient.Patient status/outcome reported as fine.No additional information is available.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

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

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (part number 08.520.221s, lot number dcs0059, synpor smooth titanium reinforced fan plate).Two synpor smooth titanium reinforced fan plates (lot numbers dcs0059 and dcs7707) were received with the complaint that the plates delaminated before implanting them.Though the original packaging was returned with the plates, the plates were not returned within the original packaging or labeled, therefore it is unknown which plate is associate with which lot.The plates were each received showing delamination.The first plate appears to have been cut roughly in half.On one half, approximately 30% of the titanium has been additionally cut away.The cut portion was not returned.The entire smooth layer and approximately 95% of the porous layer are missing on the pieces of the first plate.The second plate has been cut such that approximately 30% is missing.The smooth and porous layers are present; however, slight peeling of the smooth layer was noted on the cut edge.The balance of each plate shows bending and is in otherwise working condition.Thus, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the devices are already showing delamination.Further evaluation shows that the synpor porous polyethylene implants are intended for use in non-load bearing application.The titanium reinforced fan plates are porous sheets embedded with the fan-shaped 1.3mm titanium orbital floor plate.This information is provided per the synpor porous polyethylene implants technique guide.A review of the current design / manufactured revision was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.A manufacturing investigation was performed by (b)(4).The supplier reported that various defects could be observed in both devices.One device appears to have been cut, with the smaller section not returned.Part of the uhmwpe could be observed beginning to separate from the titanium plate.The other device was returned in two pieces which cannot be matched up.This device also appears to have been cut, with observable marks and bends, and has only a small amount of porous uhmwpe remaining.Review of all manufacturing and inspection records for lots c7707 and 00059 indicate no process or inspection deviations or non-conformances related to the failure mode.No conclusive root cause can be assigned for the reported delamination of the synpor plates, part number 80012-02, lots c7707 and 00059.A root cause could not be definitely determined.However, no design or manufacturing issues were identified.Thus, it is probable that the method of use may have contributed to the complaint condition.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 TI REINFORCED FAN PL FIXTN H/0.8MM THK-STER
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5307166
• MDR Text Key: 34612634
• Report Number: 1719045-2015-10828
• Device Sequence Number: 1
• Product Code: GWO
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Catalogue Number: 08.520.221S
• Device Lot Number: DSD0059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 59 YR