REVITAN, RASP ADAPTER WITH LENGTH MARKINGS N/A 01.00409.501

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-07 for REVITAN, RASP ADAPTER WITH LENGTH MARKINGS N/A 01.00409.501 manufactured by Zimmer Gmbh.

Event Text Entries

[116706562] This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states (b)(4). The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation. As no lot number was provided, the device history records could not be reviewed. An e-mail requesting the following additional information was sent on (b)(6) 2018 to the appropriate representatives. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. Zimmer biomet? S reference number of this file is (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[116706563] It was reported that during the surgery, the rear portion of the handle of the revitan, rasp adapter with length markings has broken off and the surgery was completed with the defective instrument. No surgery delay has been reported. Notes: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument. Hence, no expiration date is captured, for the same reason.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0009613350-2018-00688
MDR Report Key7755620
Date Received2018-08-07
Date of Report2018-10-11
Date of Event2018-06-14
Date Mfgr Received2018-10-03
Device Manufacturer Date2012-09-17
Date Added to Maude2018-08-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER GMBH
Manufacturer StreetSULZER ALLEE 8 SULZER INDUSTRIE PARK
Manufacturer CityWINTERTHUR 8404
Manufacturer CountrySZ
Manufacturer Postal Code8404
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report0

Device Details

Brand NameREVITAN, RASP ADAPTER WITH LENGTH MARKINGS
Generic NameN/A
Product CodeHTR
Date Received2018-08-07
Returned To Mfg2018-07-25
Model NumberN/A
Catalog Number01.00409.501
Lot Number12.783902
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerZIMMER GMBH
Manufacturer AddressSULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-07

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