MIS, RASP HANDLE, DOUBLE OFFSET, LEFT N/A 01.00001.003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-09 for MIS, RASP HANDLE, DOUBLE OFFSET, LEFT N/A 01.00001.003 manufactured by Zimmer Gmbh.

Event Text Entries

[116874656] (b)(4). The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[116874657] It was reported that the rasp handle was stuck in the lock position. The surgeon had to use another device to complete the surgery.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0009613350-2018-00786
MDR Report Key7766599
Date Received2018-08-09
Date of Report2018-12-07
Date of Event2018-07-23
Date Mfgr Received2018-11-27
Device Manufacturer Date2017-09-28
Date Added to Maude2018-08-09
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 NameMIS, RASP HANDLE, DOUBLE OFFSET, LEFT
Generic NameN/A
Product CodeHTR
Date Received2018-08-09
Returned To Mfg2018-09-27
Model NumberN/A
Catalog Number01.00001.003
Lot Number4501770665
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 2018-08-09

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