MAUDE Adverse Event Report: SYNTHES MONUMENT NORIAN DRILLABLE INJECT 3CC-STERILE; FILLER, CALCIUM SULFATE PREFORMED PELLETS

Catalog Number 07.704.003S

Device Problems Filling Problem (1233); Difficult to Insert (1316); Appropriate Term/Code Not Available (3191)

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

Event Date 03/31/2016

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.(b)(4) not able to inject/roll out the mixture into the syringe.Device history records was conducted.The report indicates that the dhr review part number: 07.704.003s, synthes lot number: dsd0256, release to warehouse date: 19-oct-2015 expiration date: 28-apr-2017, manufacturing site is (b)(4) and supplied by dsm biomedical.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.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 right tibial plateau open reduction internal fixation (orif) surgery the rotary mixer broke and prevented mixing of the norian mixture.It was then noticed that hinge in the back of the rotary mixer is also broken.Another rotary mixer was used to complete the surgery, however, by the time he finished mixing norian, he was not able to roll out the mixture into the syringe.The surgeon used cancellous chips to complete the surgery.There was approximately 5 to 10 minute surgical delay due to reported event.Surgery was completed successfully without any other medical intervention required.It was confirmed via phone on (b)(6) 2016 that he was helping nurse in or suite (not in sterile field) with mixer of norian as it was requested by surgeon.No sterile product was touch in any way.Patient status reported as good.This complaint involves 2 devices.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.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 product investigation was completed: one norian drillable device (part number 07.704.003s, lot number dsd0256) was received at customer quality (cq) for investigation.The device was intact with the delivery syringe still attached to the pouch and the pouch appearing to still contain the dried/cured product.Additionally, the liquid syringe was empty.No issues were found with the returned norian device.The cause of the difficulty rolling out the biomaterial was due to improper mixing caused by the broken mixer.A visual inspection, device history record review, drawing review, and risk assessment review were performed as part of this investigation.No product design/manufacture issues or discrepancies were observed.This complaint is confirmed.The relevant drawings for the device(s) were reviewed.No drawing issues or discrepancies were noted.The design was determined to be suitable for the intended use when employed and maintained as recommended.Proper use and maintenance for the device(s) are addressed in technique guides.The device is used for filling bony voids before or after final fixation.A review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The cause of the difficulty rolling out the biomaterial was due to improper mixing caused by the broken mixer.No manufacturing or design issues were noted during the investigation.The design is determined to be adequate for its intended use when used and maintained as recommended.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.

• Brand Name: NORIAN DRILLABLE INJECT 3CC-STERILE
• Type of Device: FILLER, CALCIUM SULFATE PREFORMED PELLETS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5577818
• MDR Text Key: 42762208
• Report Number: 1719045-2016-10318
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK102722
• 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: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2017
• Device Catalogue Number: 07.704.003S
• Device Lot Number: DSD0256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 91