MAUDE Adverse Event Report: SYNTHES MONUMENT RIA TUBE ASSEMBLY MIN 520MM LENGTH-STERILE FOR 314.743; REAMER

Catalog Number 314.746S

Device Problem Complete Blockage (1094)

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

Event Date 10/29/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Device is an instrument and is not implanted or explanted.Per facility, the complainant parts were discarded and are not available for investigation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history review: manufacturing date: august 15, 2015 - expiration date: july 31, 2017 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.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 surgeon was filling a bone void utilizing a reamer irrigator aspirator (ria) system to ream out a canal for a bone graft when the tube assembly became clogged.Some graft was lost due to the clogging.A second part was used and this one had difficulty as well.The surgeon was not sure if it was a suction issue, an irrigation issue, or if he went too fast.A ten (10) to fifteen (15) minute delay was reported, but the procedure was completed successfully.This report is 2 of 2 for (b)(4).

• Brand Name: RIA TUBE ASSEMBLY MIN 520MM LENGTH-STERILE FOR 314.743
• Type of Device: REAMER
• 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: 5225817
• MDR Text Key: 31334613
• Report Number: 1719045-2015-10736
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111437
• 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
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 314.746S
• Device Lot Number: 7977825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 64 YR