BONE COLLECTOR B-COLLECTOR-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-02-07 for BONE COLLECTOR B-COLLECTOR-1 manufactured by Depuy Synthes Power Tools.

Event Text Entries

[66779720] (b)(4). The actual device has been returned and is currently pending evaluation. Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[66779721] This is report 2 of 2 for the same event: it was reported that during an unspecified surgical procedure, it was observed that the suction port stems separated from their respective collection chambers of two bone collector devices while the stems were still inside the suction tubing. The reporter was uncertain whether the devices separated before or after the stems were ready to be used to join the suction tubes together. The reporter stated that the breakage occurred at the central filter's snap-off union where the double male connection allowed for the joining of the two suction tube ends once the device was removed from between the two suction tubes. The reporter further stated that the user? Nurse? Was not yet trained on the proper usage of the device and therefore, applied too much pressure while connecting/disconnecting the suction tubing to the device, resulting in the device to snap-off. It was reported that the second device was pulled and the user repeated the same technique which resulted in another malfunction of the device. The reporter further stated that the issue occurred as a result of user error due to proper assembly and from applying too much pressure. There were no delays to the surgical procedure as spare devices were available to complete the surgery successfully. There was patient involvement reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5


[67682039] Additional narrative: correction: upon further review of this complaint, it was determined that there was no alleged malfunction against the devices as they performed as intended by snapping off. Therefore, this complaint is not reportable. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1045834-2017-10344
MDR Report Key6307067
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-02-07
Date of Report2017-01-23
Date of Event2017-01-23
Date Mfgr Received2017-02-14
Date Added to Maude2017-02-07
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 ContactRODNEY CRAIN
Manufacturer Street4500 RIVERSIDE DRIVE
Manufacturer CityPALM BEACH GARDENS FL 33410
Manufacturer CountryUS
Manufacturer Postal33410
Manufacturer Phone5616271080
Manufacturer G1DEPUY SYNTHES POWER TOOLS
Manufacturer Street4500 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 NameBONE COLLECTOR
Generic NameBONE PARTICLE COLLECTOR - BONE COLLECTOR
Product CodeMXP
Date Received2017-02-07
Returned To Mfg2017-01-27
Catalog NumberB-COLLECTOR-1
Lot Number3019130831
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDEPUY SYNTHES POWER TOOLS
Manufacturer Address4500 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410


Patients

Patient NumberTreatmentOutcomeDate
10 2017-02-07

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