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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL SA AO REAMER ATTACHMENT 350 RPM

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ZIMMER SURGICAL SA AO REAMER ATTACHMENT 350 RPM Back to Search Results
Catalog Number 89-8509-435-10
Device Problems Blocked Connection (2888); Protective Measures Problem (3015); Handpiece (3067); 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 ao reamer attachment 350 rpm, part number 89-8509-435-10, serial number (b)(4) was blocked and not functional. During the partial hip replacement surgery, a delay of 50 minutes was reported. The patient was under anesthesia. The reason for the delay was due to time needed for the diagnosis of the handpiece and search of the replacement. Another device was used to complete the surgery. There was no additional harm or injury to the patient reported.

 
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Brand NameAO REAMER ATTACHMENT 350 RPM
Type of DeviceAO REAMER ATTACHMENT 350 RPM
Manufacturer (Section D)
ZIMMER SURGICAL SA
3 chemin du pre fleuri
plan-les-ouates
geneva 1228
SZ 1228
Manufacturer (Section G)
ZIMMER SURGICAL SA
3 chemin du pre fleuri
plan-les-ouates
geneva 1228
SZ 1228
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key8234632
MDR Text Key132764966
Report Number0008031000-2019-00003
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeMO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number89-8509-435-10
Device LOT Number5009614
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/30/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/10/2019 Patient Sequence Number: 1
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