• 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 7MM TI MULTILOC HUMERAL NAIL LEFT/CANN/240MM-STERILE ROD,FIXATION,INTRAMEDULLARY

  • 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 7MM TI MULTILOC HUMERAL NAIL LEFT/CANN/240MM-STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.017.240S
Device Problems Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Complainant part is not expected to be returned for manufacturer review/ investigation. Occupation: reporter is a j&j sales representative. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a surgery of osteosynthesis of left humerus, with multiloc nail system. During the surgery, the nail to remain outside about 3mm. There was no fragment generated. The surgery was completed successfully. The patient outcome was unknown. This complaint involves one (1) device. This report is for (1)7mm ti multiloc humeral nail left/cann/240mm-sterile. This report is 1 of 1 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name7MM TI MULTILOC HUMERAL NAIL LEFT/CANN/240MM-STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
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 Key12025021
MDR Text Key268304586
Report Number8030965-2021-05067
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K120807
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.017.240S
Device Lot Number67P8294
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 Received06/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

-
-