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

MAUDE Adverse Event Report: SYNTHES GMBH TFNA FEM NAIL Ø11 LE 130° L235 TIMO15 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

  • 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 GMBH TFNA FEM NAIL Ø11 LE 130° L235 TIMO15 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.145S
Device Problem Break (1069)
Patient Problems Bone Fracture(s) (1870); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
Device report from synthes reports an event in (b)(6). It was reported on an unknown date that the trochanteric fixation nail - advanced (tfna) was broken and revision surgery was necessary. This report is for one (1) 11mm/130 deg ti cann tfna 235mm/left - sterile. This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
Product complaint #
==
> (b)(4). Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Initial reporter address: (b)(6). Reporter is a (b)(6). (b)(4). The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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 NameTFNA FEM NAIL Ø11 LE 130° L235 TIMO15
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14567495
MDR Text Key293106266
Report Number8030965-2022-03601
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819650534
UDI-Public(01)07611819650534
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.145S
Device Lot Number25P1417
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2019
Is the Device Single Use? Yes

Patient Treatment Data
Date Received: 06/01/2022 Patient Sequence Number: 1
-
-