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

MAUDE Adverse Event Report: SYNTHES SELZACH 8.5MM MEDULLARY REAMER HEAD

  • 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 SELZACH 8.5MM MEDULLARY REAMER HEAD Back to Search Results
Catalog Number 352.085
Device Problems Break; Material Fragmentation
Event Type  Malfunction  
Manufacturer Narrative

Device was used for treatment, not diagnosis. Additional narrative: patient information was not provided by reporter. Event date: unknown. Although requested, additional information was not provided for reporting. Device is an instrument and is not implanted/explanted. A device history record review was performed for the subject device lot. The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. No non-conformances were generated during the production of the subject device. A product development investigation was performed for the subject device. The reamer head was found to be broken on the proximal end of the device (missing approximately 8mm x 7mm segment ¿ measured with calipers ca94). The complaint condition was confirmed. The flexible shaft (352. 040) and 8. 5mm reamer head (352. 085) are utilized in operations when reaming is utilized and is noted in eight (8) technique guides including: titanium cannulated tibial nail, adolescent lateral entry femoral nail (alif) and reamer/irrigator/aspirator (ria). In use, a cutting head (starting with 8. 5mm and moving up in 0. 5mm increments) is attached to the distal end of the flexible shaft and inserted under power over a reaming rod per the titanium cannulated tibial nail technique guide. The relevant drawing for the returned instrument was reviewed. The design, materials and finishing processes were found to be appropriate for the intended use of these devices. No definitive root cause was able to be determined as method of use at time of failure is unknown. The received condition is consistent with the reamer head becoming stuck during use resulting in a twisted/broken flexible shaft tip and a broken reamer head. 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 an 8. 5mm medullary reamer head and a 5. 0 flexible reamer shaft broke during a tibial nail procedure on an unknown date. This report is 1 of 2 for (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name8.5MM MEDULLARY REAMER HEAD
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES SELZACH
bohnackerweg 5
selzach CH254 5
SZ  CH2545
Manufacturer (Section G)
SYNTHES SELZACH
bohnackerweg 5
selzach CH254 5
SZ  CH2545
Manufacturer Contact
linda plews
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key5449469
Report Number3000270450-2016-10034
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/26/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352.085
Device LOT Number26062
OTHER Device ID Number(01)10886982194176(10)26062
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/11/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/24/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-