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 SA UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER 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 SA UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE Back to Search Results
Catalog Number 89-8507-400-00
Device Problems Mechanical Jam (2983); Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 07/02/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device was not returned to the manufacturer at the date of this report.A follow-up medwatch will be submitted once the investigation is completed or if any additional information is received.
 
Event Description
It was reported that the universal modular electric/battery double trigger handpiece part number 89-8507-400-00 serial number (b)(4) was blocked and was not functional.During the partial hip replacement surgery, a delay of 50 minutes was reported.The reason for the delay was due to time needed for the diagnosis of the handpiece and search of the replacement.The patient was under anesthesia at the time of the delay.A different handpiece was used to complete the procedure.There was no additional harm or injury to patient/operator reported.
 
Manufacturer Narrative
Zimmer biomet complaint (b)(4).Universal modular electric/battery double trigger, serial number (b)(4), was not returned for complaint investigation.Therefore, the device could not be visually inspected in an effort to confirm the defect.A follow-up medwatch will be submitted if the product is returned or if additional information is received.
 
Event Description
It was reported that the universal modular electric/battery double trigger handpiece part number 89-8507-400-00 serial number (b)(4) was blocked and was not functional.During the partial hip replacement surgery, a delay of 50 minutes was reported.The reason for the delay was due to time needed for the diagnosis of the handpiece and search of the replacement.The patient was under anesthesia at the time of the delay.A different handpiece was used to complete the procedure.There was no additional harm or injury to patient/operator reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
Type of Device
UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
Manufacturer (Section D)
ZIMMER SURGICAL SA
3, ch. du pre fleuri
plan-les-ouates, geneva 1228
SZ  1228
MDR Report Key8239060
MDR Text Key132763446
Report Number0008031000-2019-00010
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number89-8507-400-00
Device Lot Number5006403
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received12/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age32 YR
Patient Weight76
-
-