Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DERMATOME AN HANDPIECE
  • 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
 

ZIMMER SURGICAL, INC. DERMATOME AN HANDPIECE Back to Search Results
Catalog Number 88710100
Device Problem Failure to Cut (2587)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2019
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).The investigation is still in progress.Once the investigation is complete a final mdr will be submitted.
 
Event Description
It has been reported that the graft was too thick/shred.The device shredded the graft, giving the graft a swiss cheese look.They took 3 total grafts, and of the 3, 2 were able to be used.It is unknown if the 3rd was able to be used.No additional graft was taken.No adverse events were reported as a result of this malfunction.
 
Manufacturer Narrative
This report is being submitted as a correction.The initial report was created in error and should be voided.The event will be reported on mfr number 001526350-2019-01187 associated with (b)(4).
 
Event Description
No additional information.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DERMATOME AN HANDPIECE
Type of Device
DERMATOME
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
MDR Report Key9520451
MDR Text Key197765703
Report Number0001526350-2019-01190
Device Sequence Number1
Product Code GFD
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number88710100
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
-
-