INSERTION JIG 130 DEGREE 1.5M N/A 211201211

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-10-04 for INSERTION JIG 130 DEGREE 1.5M N/A 211201211 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[88159077] Zimmer biomet complaint - (b)(6). Complaint sample was evaluated and the reported event was not confirmed. Product left conforming to print as there was no evidence that states otherwise. Per engineer,? The only thing that can be said is that they need to put the a/r guide in with the lag screw guide tube as described on page 20 of the attached surgical technique. If they follow this technique then they will see that there is resistance on the a/r guide tube.? Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no trends were identified. Investigation results concluded that the reported event was related to surgical technique. The condition is addressed in the surgical technique. 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


[88159078] It was reported that multiple insertion jigs have a loose sheath, the spring in jig does not work properly, and a screw is missing on one product.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001825034-2017-07855
MDR Report Key6913570
Report SourceDISTRIBUTOR,FOREIGN
Date Received2017-10-04
Date of Report2017-10-03
Date of Event2015-01-05
Date Mfgr Received2015-01-05
Device Manufacturer Date2014-06-17
Date Added to Maude2017-10-04
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 NameINSERTION JIG 130 DEGREE 1.5M
Generic NameORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Product CodeLHX
Date Received2017-10-04
Model NumberN/A
Catalog Number211201211
Lot NumberCX0614X01
ID NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET, INC.
Manufacturer Address56 E. BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
10 2017-10-04

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