• 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 HN MULTILOC Ø7 DCHO CAN L255 TAN 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 HN MULTILOC Ø7 DCHO CAN L255 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.016.255S
Device Problem Migration (4003)
Patient Problem Pain (1994)
Event Date 02/02/2022
Event Type  Injury  
Event Description
Multiloc humeral nail removal due to nail backing out. X2 multiloc screws removed and x1 4mm locking screw (both unknown reference/lot numbers). This complaint involves one(1) device hn multiloc ø7 dcho can l255 tan. This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4). 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. Product was not returned. 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 NameHN MULTILOC Ø7 DCHO CAN L255 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13651323
MDR Text Key286431396
Report Number8030965-2022-01270
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K120807
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.016.255S
Device Lot Number2L98449
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2019
Is the Device Single Use? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/02/2022 Patient Sequence Number: 1
Treatment
UNK - NAIL HEAD ELEMENTS: MULTILOC HUMERAL SCREW; UNK - NAIL HEAD ELEMENTS: MULTILOC HUMERAL SCREW; UNK - SCREWS: 4.0 MM NAIL LOCKING SCREW
-
-