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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 Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/22/2014
Event Type  malfunction  
Event Description
It was reported by the surgeon 'the implants were fine after impaction and one of the proximal condyles broke off when the finger was reduced.Reduction was not too tight.The surgeon used a dorsal approach.This occurred during reduction after implantation.There was no delay in the surgery time.The surgery was completed with a spare device that was available'.
 
Manufacturer Narrative
To date, the device involved in the reported incident has not been rec'd for evaluation.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 drive
plainsboro, NJ 08536
6099362341
MDR Report Key3995282
MDR Text Key4952025
Report Number1651501-2014-00028
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
Reporter Occupation Other
Type of Report Initial
Report Date 05/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number12-2380
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/23/2014
Initial Date FDA Received06/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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