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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL SA MOD ELEC/BATT DBL TRIG HP MOD ELEC/BATT DBL TRIGGER HANDPIECE

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ZIMMER SURGICAL SA MOD ELEC/BATT DBL TRIG HP MOD ELEC/BATT DBL TRIGGER HANDPIECE Back to Search Results
Catalog Number 89-8507-400-00
Device Problems Device Inoperable (1663); Handpiece (3067)
Patient Problem No Code Available (3191)
Event Date 01/19/2018
Event Type  Injury  
Manufacturer Narrative

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.

 
Event Description

It was reported that the modular electronic / battery double trigger handpiece, serial number (b)(4), stopped working. A delay in surgery of more than 30 minutes was reported as the unit used as replacement needed to be sterilize. There is no additional harm or injury to patient/operator reported. The event date in unknown, the notification date is in september 2017.

 
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Brand NameMOD ELEC/BATT DBL TRIG HP
Type of DeviceMOD ELEC/BATT DBL TRIGGER HANDPIECE
Manufacturer (Section D)
ZIMMER SURGICAL SA
3, ch. du pre fleuri
1228 plan-les-ouates, geneva CH-12 28
SZ CH-1228
Manufacturer (Section G)
ZIMMER SURGICAL SA
3, ch. du pre fleuri
1228 plan-les-ouates, geneva CH-12 28
SZ CH-1228
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key6967928
MDR Text Key89915003
Report Number0008031000-2017-00019
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeRW
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,Followup
Report Date 01/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number89-8507-400-00
Device LOT Number5005875
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 Received01/19/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/26/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 10/23/2017 Patient Sequence Number: 1
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