PIP SZ. 20 PROXIMAL PIP-200-20P-WW

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-02-12 for PIP SZ. 20 PROXIMAL PIP-200-20P-WW manufactured by Ascension Orthopedics.

Event Text Entries

[100040338] Integra has completed their internal investigation on february 1, 2018. Dhr review; no defects were noted in the dhr review that may have contributed to this complaint. Complaints history; a trackwise search of the results of the short description field containing? Pip? November 2015 to present showed 13 complaints of intra-operative pip fractures, including this one. During this period of time, there have been 3,449 pip surgeries performed. This represents 0. 377% (13/3,449) overall failure rate. Not an adverse trend. Conclusion: the root cause of the reported event is unknown. As the device has not been returned, the root cause of the report cannot not be confirmed to date. In the past, similar issues that resulted in intra-operative pip fractures have been attributed to improperly prepared oblique osteotomy, improper placement of the implant (e. G. , impacting unsupported head with too much force), or improper implant size selection.
Patient Sequence No: 1, Text Type: N, H10


[100040339] It was reported that the implant broke in 3 pieces during the procedure. The surgery was completed with a replacement implant. No patient injury or consequences and the event did not lead to surgical delay.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1651501-2018-00009
MDR Report Key7263072
Report SourceFOREIGN
Date Received2018-02-12
Date of Report2018-02-01
Date of Event2018-01-31
Date Mfgr Received2018-03-20
Device Manufacturer Date2016-12-28
Date Added to Maude2018-02-12
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 ContactUSER SONIA IRIZARRY
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1ASCENSION ORTHOPEDICS
Manufacturer Street8700 CAMERON ROAD #100
Manufacturer CityAUSTIN TX 78754
Manufacturer CountryUS
Manufacturer Postal Code78754
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePIP SZ. 20 PROXIMAL
Generic NamePIP
Product CodeNEG
Date Received2018-02-12
Returned To Mfg2018-02-28
Catalog NumberPIP-200-20P-WW
Lot Number163848T
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerASCENSION ORTHOPEDICS
Manufacturer Address8700 CAMERON ROAD #100 8700 CAMERON ROAD #100 AUSTIN TX 78754 US 78754


Patients

Patient NumberTreatmentOutcomeDate
10 2018-02-12

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