MAUDE Adverse Event Report: SYNTHES MONUMENT SYNPOR SMOOTH TI REINFORCED; PLATE,CRANIOPLASTY,PREFORMED, ALTERABLE

Catalog Number 08.520.220S

Device Problems Detachment of Device or Device Component (2907); Device Operates Differently Than Expected (2913)

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

Event Date 03/04/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional product codes: ftl, ftm.(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: dhr review for part #08.520.220s, synthes lot#dsd7781; release to warehouse date: 09-jan-2017; expiration date: 28-sep-2021; supplier: (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.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 a patient underwent an unknown procedure for a left orbital fracture on (b)(6) 2017.After cutting and shaping the fan plate, the surgeon began to implant the product when the porous sheet separated from the orbital plate.The surgeon used another available implant, adding a three minute surgical time delay to the case.The rest of the procedure was uneventful.The patient status was successful.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Manufacturing date changed to reflect the dhr date.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.(b)(6).A product development investigation was performed for the subject device (brand name synpor smooth ti reinforced fan plate 0.8mm thick-sterile, part number 08.520.220s, lot number dsd7781).The subject device was returned with the complaint condition stating that a patient underwent an unknown procedure for a left orbital fracture on (b)(6) 2017.After cutting and shaping the fan plate, the surgeon began to implant the product when the porous sheet separated from the orbital plate.The surgeon used another available implant, adding a three minute surgical time delay to the case.The rest of the procedure was uneventful.The patient status was successful.A visual inspection under 5x magnification was performed.The porous/smooth sheet was received at synthes customer quality (cq) cut into two (2) pieces, likely by the surgeon.The orbital plate portion of the implant was received without the porous sheet, therefore it is confirmed that the sheet separated from the plate.This complaint was not able to be replicated at cq because the foam sheet has already separated from the orbital plate and was not returned for evaluation.The associated tabulated product drawing made to/current revision was reviewed during this investigation.No product design issues or discrepancies were observed.As previously reported, the device history record review showed that no non-conformances were generated during production.There were no issues during the manufacture of this product that would contribute to this complaint condition.The complaint condition was confirmed although a root cause could not be determined as the porous sheet was not returned.No new, unique or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6434395
• MDR Text Key: 70879164
• Report Number: 1719045-2017-10257
• Device Sequence Number: 1
• Product Code: GWO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051879
• 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,Followup,Followup
• Report Date: 03/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Catalogue Number: 08.520.220S
• Device Lot Number: DSD7781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 49 YR