RASP HANDLE FOR CABLE - LOCKED RASPS N/A 00902900101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-06 for RASP HANDLE FOR CABLE - LOCKED RASPS N/A 00902900101 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[89422991] (b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[89422992] It was reported that while rasping the ml taper during primary total hip, the tip of the broach handle fractured causing loosening of the spring. The device was deemed the unusable. No pieces were retained in the patient. A second rasp handle was used so the case continued without issue. No patient consequences were reported. No further information has been made available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001822565-2017-06822
MDR Report Key6925733
Date Received2017-10-06
Date of Report2018-06-28
Date of Event2017-09-11
Date Mfgr Received2018-06-25
Device Manufacturer Date1998-10-22
Date Added to Maude2017-10-06
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 BIOMET, INC.
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report0

Device Details

Brand NameRASP HANDLE FOR CABLE - LOCKED RASPS
Generic NameINSTRUMENT, HIP
Product CodeHTR
Date Received2017-10-06
Returned To Mfg2017-09-11
Model NumberN/A
Catalog Number00902900101
Lot Number59082200
ID NumberN/A
OperatorPHYSICIAN
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET, INC.
Manufacturer Address56 E. BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-10-06

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