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

MAUDE Adverse Event Report: SYNTHES (USA) 14.5MM PROTECTION SLV STRAIGHTFOR 12MM-13MM NAILS; NAIL, FIXATION, BONE

  • 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 (USA) 14.5MM PROTECTION SLV STRAIGHTFOR 12MM-13MM NAILS; NAIL, FIXATION, BONE Back to Search Results
Catalog Number 03.010.436
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/19/2015
Event Type  malfunction  
Event Description
It was reported that a surgeon was using the supra-patellar tibial nail during a case and he was having problems with the protection sleeve.Surgeon was using a competitor reaming system which kept catching on the synthes protection sleeve which would then pull out from the incision.Also, the rubber protection sleeve loosened from the protection sleeve handle.Four parts where involved in the reported event, however was not certain which one(s) contributed to this issue.There was a 14 to 30 minute surgical delay due to the reported event.The procedure was successfully completed.This report is 3 of 4 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: (b)(6).Patient weight was not provided by reporter.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.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 Name
14.5MM PROTECTION SLV STRAIGHTFOR 12MM-13MM NAILS
Type of Device
NAIL, FIXATION, BONE
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 Key4956909
MDR Text Key17939425
Report Number2520274-2015-15097
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK111667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 07/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.010.436
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/19/2015
Initial Date FDA Received07/31/2015
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 Number1
Patient Age48 YR
-
-