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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS PIP SZ 20 PROXIMAL
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ASCENSION ORTHOPEDICS PIP SZ 20 PROXIMAL Back to Search Results
Catalog Number PIP-200-20P-WW
Device Problems Break (1069); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/18/2014
Event Type  malfunction  
Event Description
It was reported during the final impaction of the proximal pip implant into the pt's middle finger, the implant shattered.There was no reported injury to the pt, a spare device was available that functioned correctly.The surgery time was delayed by 5 minutes.
 
Manufacturer Narrative
The device involved in the reported incident has been received for eval.An investigation has been initiated based on the reported info.
 
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Brand Name
PIP SZ 20 PROXIMAL
Type of Device
PIP
Manufacturer (Section D)
ASCENSION ORTHOPEDICS
austin TX 78754
Manufacturer Contact
caren finkelstein
315 enterprise dr.
pliansboro, NJ 08536
6099362341
MDR Report Key4023901
MDR Text Key4803878
Report Number1651501-2014-00038
Device Sequence Number1
Product Code MPK
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
H010005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 07/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPIP-200-20P-WW
Device Lot Number13-27837
Was Device Available for Evaluation? No
Date Returned to Manufacturer08/01/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received07/23/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age64 YR
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