MAUDE Adverse Event Report: SYNTHES MONUMENT CRANIOS REINFORCED ROTARY MIX 3CC-STERILE; METHYL METHACRYLATE FOR CRANIPLASTY

Catalog Number 616.03.01S

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

The product was not used during the surgical procedure.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacturing date: april 2, 2015 - expiration date: august 28, 2016 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 the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.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 the cranios reinforced rotary product set up too quickly during a surgical procedure on (b)(6) 2015.A second package had to be opened and used.There was a ten (10) to fifteen (15) minute delay in the procedure, but it was ultimately completed successfully.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was returned without a tracking or complaint number associated with it.On (b)(4) 2015 it was determined that the returned part was associated with this complaint.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 investigation summary: the relevant norian reinforced drawing was reviewed during this evaluation and no design discrepancies were identified.The design is adequate for its intended use and did not contribute to this complaint condition.This complaint is confirmed as the returned product was visually inspected and shows evidence of set/hardened cement inside the device.Whether this complaint condition can be replicated is not applicable for this complaint as the cement was already set/hardened.Based on the complaint details, no new harms were identified as a result of this complaint.This evaluation for cranios reinforced rotary mix 3cc-sterile with complaint condition of setting up too quickly can also include norian drillable rotary products because cranios reinforced rotary and norian drillable rotary are the same product with the same chemical compositions, the same mixing method (i.E., rotary mixer), and the same delivery syringes.The only difference is that cranios reinforced rotary is for cmf applications, while norian drillable rotary is for trauma applications.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: CRANIOS REINFORCED ROTARY MIX 3CC-STERILE
• Type of Device: METHYL METHACRYLATE FOR CRANIPLASTY
• 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: 5197388
• MDR Text Key: 30245062
• Report Number: 1719045-2015-10707
• Device Sequence Number: 1
• Product Code: GXP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK102018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2016
• Device Catalogue Number: 616.03.01S
• Device Lot Number: DSC6845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 49 YR