2.7 MM LOCKING SCREW 18 MM LENGTH N/A 47482801802

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for 2.7 MM LOCKING SCREW 18 MM LENGTH N/A 47482801802 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[185258907] (b)(4). Multiple mdr reports were filed for this event, please see associated report: 0001822565-2019-00343. Medical product: distal lateral tibial plate left 6 holes 94 mm length; item# (b)(4), lot# 63139620. Source: (b)(6). Visual inspection of the returned product noted discoloration on the plate and the screw head. The returned products were sent to sem for additional evaluation. The foreign elements (c, n, o, na, mg, p, cl, k, and ca) identified in the discoloration indications on the distal lateral fibular plate and locking screw sample noted could be from various potential contaminants including biological soft tissue and bone, dried biological fluids (i. E. Blood), bone cement (calcium phosphate-based), corrosion/metal oxide product or various decontamination solutions (i. E. Hospital detergents). Therefore, the source of these elements is inconclusive. Signs of pitting corrosion observed within the locking threads on the screw sample and no indications of pitting corrosion observed on the plate sample. The eds analysis of the discoloration free area on the distal lateral fibular plate and locking screw samples showed that the elements identified in the spectra were consistent with (b)(4). Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified. A definitive root cause cannot be determined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10


[185258908] It was reported that a plate was explanted due to the customer thinking that it was linked to an ongoing investigation of the plp product at the hospital. There is no additional information available at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001822565-2020-01118
MDR Report Key9888002
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2019-01-10
Date Mfgr Received2020-03-09
Device Manufacturer Date2016-10-14
Date Added to Maude2020-03-27
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 Report3

Device Details

Brand Name2.7 MM LOCKING SCREW 18 MM LENGTH
Generic NamePLATE, FIXATION, BONE
Product CodeHRS
Date Received2020-03-27
Returned To Mfg2019-09-12
Model NumberN/A
Catalog Number47482801802
Lot Number63470831
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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. Hospitalization; 2. Required No Informationntervention 2020-03-27

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