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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 Burst Container or Vessel (1074)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/29/2014
Event Type  malfunction  
Event Description
It was reported the pip-200-20p ww lot number 14-0101t shattered during surgery (left hand surgery, unk which finger).The implant shattered during placement.The surgeon was not happy with the way the device 'sat' after placement and decided to remove it.The device was removed.There was no pt injury.The surgery time was increased approx 1 hour due to this issue.The surgery was completed with a spare device that was available and functioned properly.There were no reported injuries or adverse consequence to the pt reported.
 
Manufacturer Narrative
To date the device involved in the reported incident has not 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 drive
plainsboro, NJ 08536
6099362341
MDR Report Key4216837
MDR Text Key20267019
Report Number1651501-2014-00048
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,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 10/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2014
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 Number14-0101T
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received10/02/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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