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 Problems Material Separation (1562); Device Operates Differently Than Expected (2913)

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

Event Date 07/09/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).(b)(4).Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 an orbital floor fracture repair on (b)(6) 2016, while the surgeon was cutting and shaping the synpor smooth titanium reinforced fan plate, the porous polyethylene (ppe) delaminated from the titanium plate.Part of the ppe came off into the surgeon's hand while the rest of it remained attached to the plate.The surgeon was able to cut another plate without any issues.There was a delay of five minutes reported.The patient was implanted with one plate and one screw and the remainder of the surgery was completed as planned.The patient was reported as stable.This complaint is for one device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: 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 # 08.520.221s lot # dsd2505, release to warehouse date: 21 mar 2016, expiration date: 11/28/2020, supplier: (b)(4).No ncrs 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.Synthes manufacturing location was discovered upon receipt of subject device.(b)(4).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.

Manufacturer Narrative

A manufacturing investigation action was conducted/performed.The report indicates that the: receipt of materials: a portion of the device was returned to dsm examination.Original packaging was returned, and used to confirm identification of returned material by lot number.A certificate of decontamination, type of which was not specified, accompanied the device.The returned device was approximately 70% of the entire commercial product.The disposition of the remaining device is unknown.The device was cut into two segments.One segment was intact, the second segment had approximately 1.5mm of material removed from outer radius.Both segments had the ppe intact, fully attached to the titanium plate.Manual manipulation was unable to remove the ppe from these segments when using reasonable force required for handling or cutting activities.Due to the unknown nature of decontamination, analysis of ppe composition would be rendered moot as it was no longer in the same condition, as manufactured and therefore such testing was not performed.Investigation: dsm part number 80012-02, lot number 02505 was manufactured at dsm exton.The devices were inspected to the prescribed pre-determined acceptance criteria.There were no non­ conformances noted.Summary: no conclusive root cause can be determined.The failure mode as reported could not be confirmed.It is unknown if the segment of product not returned was the affected portion that may have had ppe delaminate as reported within the complaint.Dsm will continue to monitor for like recurrences.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.

Manufacturer Narrative

Due to the intra-operative issues encountered, the complainant part was not implanted or explanted.Additional investigation information: the device was cut into two (2) segments.One segment was intact, but approximately 1.5mm of material from the second segment was removed from the outer radius.Both segments had the ppe intact and fully attached to the titanium plate.Note: the result/conclusion codes reported on the (b)(6) 2016 supplemental report remain applicable.No new codes required.(b)(6).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.

• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5822822
• MDR Text Key: 50461267
• Report Number: 2520274-2016-13653
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2020
• Device Catalogue Number: 08.520.221S
• Device Lot Number: DSD2505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28 YR