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. ZIMMER AIR DERMATOME
  • 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. ZIMMER AIR DERMATOME Back to Search Results
Model Number N/A
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2021
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Telephone number (b)(6).Investigation competed.This is an initial final report submission.Review of the most recent repair record determined the repair site confirmed the reported event and found that the unit was out of calibration and the control bar position was not correct.The shaft bearings, sleeve bearings, machined head, pin, screws, needle bearing, reciprocating arm, and external e-ring were replaced and resolved the reported issue.It was noted that 2,3, and 4 inch width plates were found to be damaged and returned unrepaired.It was found that the unit has not been returned for annual preventative maintenance.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.
 
Event Description
It has been reported that outside the surgical environment the device was not working as the little blade was loose and moving.At product evaluation investigation it was noted that 2,3, and 4 inch width plates were found to be damaged.No adverse events were reported as a result of this malfunction.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Telephone number (b)(6).Investigation competed.This is an initial final report submission.Review of the most recent repair record determined the repair site confirmed the reported event and found that the unit was out of calibration and the control bar position was not correct.The shaft bearings, sleeve bearings, machined head, pin, screws, needle bearing, reciprocating arm, and external e-ring were replaced and resolved the reported issue.It was noted that 2,3, and 4 inch width plates were found to be damaged and returned unrepaired.It was found that the unit has not been returned for annual preventative maintenance.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.
 
Event Description
It has been reported that outside the surgical environment the device was not working as the little blade was loose and moving.At product evaluation investigation it was noted that 2,3, and 4 inch width plates were found to be damaged.No adverse events were reported as a result of this malfunction.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ZIMMER AIR DERMATOME
Type of Device
DERMATOME
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer (Section G)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key13592416
MDR Text Key286243349
Report Number0001526350-2022-00172
Device Sequence Number1
Product Code GFD
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/24/2022
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 Model NumberN/A
Device Catalogue Number00880100100
Device Lot Number33428100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/16/2022
Initial Date FDA Received02/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/03/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
-
-