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

Catalog Number 314.746S

Device Problem Separation Failure (2547)

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

Event Date 12/07/2014

Event Type  malfunction  

Event Description

It was reported that while reaming for reamer/irrigator/aspirator (ria) using a 14.0mm reaming head the ria drive shaft broke where it connected to the jacobs chuck.It was reported that seal was a cover on the end of the drive shaft and came off with broken drive shaft tip.Broken drive shaft tip and seal were retrieved.Reaming procedure was almost complete upon breakage and reaming was successfully completed using synthes flexible reamer.Patient was not affected and surgery was continued without delay.Additionally, post-operatively the ria drive shaft was unable to be disconnected from the ria tube assembly on the back-table but was able to disconnect by sterile processing department (spd).This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Additional product code: hrx.Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: RIA TUBE ASSEMBLY MIN 520MM LENGTH-STERILE FOR 314.743
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4384704
• MDR Text Key: 18091318
• Report Number: 2520274-2015-10067
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.746S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1