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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK,A JOHNSON AND JOHNSON COMPANY RIGIDFIX; SOFT TISSUE FIXATION DEVICE
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DEPUY MITEK,A JOHNSON AND JOHNSON COMPANY RIGIDFIX; SOFT TISSUE FIXATION DEVICE Back to Search Results
Model Number 210815
Device Problem Material Fragmentation (1261)
Patient Problems Pain (1994); Foreign Body In Patient (2687)
Event Date 04/26/2013
Event Type  malfunction  
Event Description
Patient underwent an arthroscopic left knee anterior cruciate ligament (acl) reconstruction using bone-patellar tendon-bone allograft.The patient experienced a typical post-op course until sharp knee pain led to an emergency department visit 11 months post-surgery.X-rays revealed a 1 inch linear metallic object within bone with - inch extending out into tissue.Surgery for retrieval of the object was required and performed without difficulty.The object was a retained fragment of a metal rigidfix cannula which had been used with the cross pin system at the time of the original surgery.
 
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Brand Name
RIGIDFIX
Type of Device
SOFT TISSUE FIXATION DEVICE
Manufacturer (Section D)
DEPUY MITEK,A JOHNSON AND JOHNSON COMPANY
325 paramount drive
raynham MA 02767
MDR Report Key3750580
MDR Text Key4469432
Report Number3750580
Device Sequence Number1
Product Code HTY
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/25/2014
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 Invalid Data
Device Model Number210815
Device Catalogue Number210815
Device Lot Number601061
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/25/2014
Device Age1 YR
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer04/15/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/25/2014
Patient Sequence Number1
Patient Age32 YR
Patient Weight99
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