MAUDE Adverse Event Report: SYNTHES MONUMENT DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA; REAMER

Catalog Number 314.743

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 07/18/2017

Event Type  malfunction  

Manufacturer Narrative

Additional product code: hrx.(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the drive shaft for use with reamer/irrigator/aspirator (ria) was used to extract bone from the femoral medullary cavity on (b)(6) 2017.Surgeon stated the tip of the ria driver shaft was broken.It was also stated that the attachment of the ria drive shaft to the locking clip was not sufficient and the ria drive shaft was detached from the locking clip during the procedure.The device was checked post-operatively and found to have a broken tip.The broken fragment was found within the ria tube assembly.Post-operative image confirmed no fragments remained in the patient.Procedure was completed successfully with a delay of approximately 10 minutes and no harm to patient.Patient status reported as good.Concomitant devices reported: locking clip (part number unknown, lot number unknown, quantity 1), ria tubing assembly (part number unknown, lot number unknown, quantity 1), ria reamer head (part number unknown, lot number unknown, quantity 1) this report is for one (1) drive shaft for use with ria this is report 1 of 1 for (b)(4).

• Brand Name: DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6807376
• MDR Text Key: 83750580
• Report Number: 1719045-2017-10810
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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