RETAINING 2.5MM HEX DRIVE R LONG RHL2.5

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 2020-01-24 for RETAINING 2.5MM HEX DRIVE R LONG RHL2.5 manufactured by Zimmer Dental.

Event Text Entries

[182961258] One retaining 2. 5mm hex drive r long (rhl2. 5) and one impl tapered scr-v sbm 4. 7mm 4. 5mm 11. 5mm (tsvwb11) were returned for investigation. Visual inspection of the as returned products identified signs of use on the tool, dried blood and bone on the implant and no apparent fracture. Functional testing was performed for the returned products, which determined the devices failed functional testing and the reported event (does not disengage), was recreated as the devices stuck together when engaged. Functional testing to recreate the reported event (fracture) could not be performed due to the nature of the devices & event. The reported device (rhl2. 5) is associated with ca2203, scar14023 and hhe2014-120. This item/lot combination was included in recall zfa2014-120. As distribution of subject product has been discontinued, no further corrective actions are required at this time. No pre-existing conditions were noted on the per, the patient had unknown bone density. The reported devices were used on an unknown tooth and were used for an unknown duration. Dhr reviews were completed for the subject lot numbers (62735177). It was confirmed that all operations and inspections were executed as per applicable procedure. No deviations or non-conformances, which could have caused or contributed to the reported events were noted as part of the dhrs. Lots were inspected and passed all acceptance criteria by qa. Complaint history review was performed for the tool's reported lot number (62735177) for similar events and one other complaint was identified. November post market trending was reviewed and there were no actionable events or corrective actions for the reported events (does not disengage, fracture) or devices (rhl2. 5 & tsvwb11). Therefore, based on the available information, device malfunction did occur for both reported devices and the reported event (does not disengage) was confirmed for both devices as the devices stuck when engaged, while the reported event (fracture) of the driver was unconfirmed as no fracture was identified during visual inspection. Zimmer biomet complaint (b)(4). Age: not provided. Patient weight: not provided. Initial reporter fax number: not provided.
Patient Sequence No: 1, Text Type: N, H10


[182961259] It was reported that a driver (rhl2. 5) got stuck within the implant and then fractured. Doctor was able to complete the procedure using another implant. Upon investigation of the returned device, fractured driver was unable to be confirmed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002023141-2020-00166
MDR Report Key9629156
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-01-24
Date of Report2020-01-24
Date of Event2019-09-27
Date Mfgr Received2020-01-21
Device Manufacturer Date2014-06-05
Date Added to Maude2020-01-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS SUSANNE TAYLOR
Manufacturer Street4555 RIVERSIDE DRIVE
Manufacturer CityPALM BEACH GARDENS FL 33410
Manufacturer CountryUS
Manufacturer Postal33410
Manufacturer Phone5617766700
Manufacturer G1ZIMMER DENTAL
Manufacturer Street4555 RIVERSIDE DRIVE
Manufacturer CityPALM BEACH GARDENS FL 33410
Manufacturer CountryUS
Manufacturer Postal Code33410
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRETAINING 2.5MM HEX DRIVE R LONG
Generic NameDENTAL DRIVER
Product CodeNDP
Date Received2020-01-24
Returned To Mfg2019-10-28
Catalog NumberRHL2.5
Lot Number62735177
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerZIMMER DENTAL
Manufacturer Address4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.