PIP BROACH, PROXIMAL, SIZE 40 SILICONE PIP 170869

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-26 for PIP BROACH, PROXIMAL, SIZE 40 SILICONE PIP 170869 manufactured by Stryker Gmbh.

Event Text Entries

[139975582] Once the investigation has been completed any additional information will be reported in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10


[139975583] The following event was reported: "during pip silicone ancillary use: small metal debris were observed when using proximal and distal raps". We observed metal debris as soon as the proximal rasps 30 and 40 and the distal rasps 20 and 30 were impinged.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0008031020-2019-00322
MDR Report Key8453839
Date Received2019-03-26
Date of Report2019-07-25
Date of Event2019-03-04
Date Mfgr Received2019-07-01
Device Manufacturer Date2016-01-29
Date Added to Maude2019-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ANNA JUSINSKI
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1STRYKER GMBH
Manufacturer StreetBOHNACKERWEG 1 POSTFACH
Manufacturer CitySELZACH 2545
Manufacturer CountryCH
Manufacturer Postal Code2545
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePIP BROACH, PROXIMAL, SIZE 40 SILICONE PIP
Generic NamePROSTHESIS, FINGER, CONSTRAINED, POLYMER
Product CodeKYJ
Date Received2019-03-26
Catalog Number170869
Lot Number15232
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER GMBH
Manufacturer AddressBOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-03-26

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