• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES MONUMENT RIA TUBE ASSEMBLY MIN 520MM LENGTH-STERILE FOR 314.743 REAMER Back to Search Results
Catalog Number 314.746S
Device Problems Break; Material Fragmentation; Difficult to Advance
Event Date 08/22/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device is an instrument and is not implanted/explanted. (b)(6). (b)(4). Device is expected to be received. Not yet received by manufacturer. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 on (b)(6) 2016, the patient underwent intramedullary reaming of right femur surgery. During the surgery, the ria system for bone graft harvesting over the 2. 5mm synream reaming rod was used, in the described technique and as per surgical technique guide. On the retrieval of the instrument from the femoral canal, it was noted that the plastic tubing close to the tip of the ria tube assembly had worn away leaving a hole in the plastic. During the procedure the advancement of the reamer instrument was difficult at some points and appeared to get caught in the proximal shaft of the femur before more axial force was applied in order to advance it down the canal further. On inspecting the bone graft that was harvested, the surgeon retrieved a macroscopic piece of debris from the bone graft but could not find any other debris in the harvested material. The surgeon was satisfied that the harvested graft was ok to implant into the patient. No delay in surgery. No adverse event reported one day post-op. On (b)(6) 2016 clarification was received that the device broke and a piece of plastic was missing on the device. This is report 1 of 1 for (b)(4).

 
Manufacturer Narrative

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

Device history record review for part 314. 746s, lot 9820602: release to warehouse date: september 24, 2015. Expiration date: september 2017. Supplier: (b)(6). 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 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRIA TUBE ASSEMBLY MIN 520MM LENGTH-STERILE FOR 314.743
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer (Section G)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key5928726
Report Number1719045-2016-10666
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/22/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/06/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date09/01/2017
Device Catalogue Number314.746S
Device LOT Number9820602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/24/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

-
-