REVITAN, RASP, DISTAL, CURVED, 16/140 N/A 01.00409.613

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-11-29 for REVITAN, RASP, DISTAL, CURVED, 16/140 N/A 01.00409.613 manufactured by Zimmer Gmbh.

Event Text Entries

[93256786] X-rays and photographs were received and will be reviewed as part of ongoing investigation. The device was received, the investigation is pending. The device history records were reviewed and found to be conforming. Additional information has been requested and is currently not available. 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). The actual device reported in section d is not marketed in usa, but devices with similar characteristics (i. E cls brevius kinectiv rasp sz8) are marketed in usa, and therefore this report was filed.
Patient Sequence No: 1, Text Type: N, H10


[93256787] It was reported that during a surgery on (b)(4) 2017 the revitan, rasp, distal, curved, 16/140 could not be removed from the femur as expected. While removing the rasp it got broken. It was also reported that the surgery was delayed for 120 minutes. 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 Number0009613350-2017-01683
MDR Report Key7068571
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2017-11-29
Date of Report2018-04-09
Date of Event2017-11-06
Date Mfgr Received2018-04-05
Device Manufacturer Date2014-12-24
Date Added to Maude2017-11-29
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 Report3

Device Details

Brand NameREVITAN, RASP, DISTAL, CURVED, 16/140
Generic NameN/A
Product CodeHTR
Date Received2017-11-29
Returned To Mfg2017-11-22
Model NumberN/A
Catalog Number01.00409.613
Lot Number14.095943
ID NumberUNKNOWN
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
101. Hospitalization; 2. Required No Informationntervention 2017-11-29

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