DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2015, IT WAS NOTICED THAT A SET OF INSTRUMENTS WERE EXTREMELY STAINED / RUSTED. THERE WERE CONCERNS OF STERILITY AND THE COMPLETE SET UP WAS TAKEN DOWN WHICH DELAYED THE SURGICAL PROCEDURE BY 60 TO 90 MINUTES. NO PATIENT INJURY. ITEMS TO BE RETURNED: BM066R X 1 : TC MAYO-HEGAR NDL HOLDERHVYSERR185MM, BM019R X 2 : TC CRILE-WOOD NDL HLDRSTD SERR 200MM, BM016R X 1 : TC CRILE-WOOD NDL HLDRSTRSERR 145MM, BM012R X 1 : TC HALSEY NEEDLE HOLDER SERR 130MM, BH111R X 2 : HALSTED-MOSQUITO FORCEPS DEL CVD125MM.
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Patient 1
MANUFACTURING SITE EVALUATION: EVALUATION ON GOING.
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Patient 1
(B)(4). DEVICES RECEIVED FOR EVALUATION INCLUDE: BM066R X 1 MANUFACTURING CODE -7573P; MANUFACTURE DATE IS 2005. HEAVY RUST COLORED STAINING AT THE DISTAL TIP. SHOWS SIGNS OF PRIOR REPAIR. BM019R X 2: MANUFACTURING CODE -AT0AL; MANUFACTURE DATE IS 2008. HEAVY RUST COLORED STAINING AT THE DISTAL TIP. SHOWS SIGNS OF PRIOR REPAIR. MANUFACTURING CODE -G5098; MANUFACTURE DATE IS 2014. MODERATE RUST COLORED STAINING AT THE DISTAL TIP. NO SIGNS OF PRIOR REPAIR (TAPE MARKS). BM016R X 1 MANUFACTURING CODE - G5547; MANUFACTURE DATE IS 2014. MODERATE RUST COLORED STAINING AT THE DISTAL TIP. NO SIGNS OF PRIOR REPAIR (TAPE MARKS). BM012R X 1 MANUFACTURING CODE - G53K6; MANUFACTURE DATE IS 2014. HEAVY RUST COLORED STAINING AT THE DISTAL TIP. NO SIGNS OF PRIOR REPAIR (TAPE MARKS). BH111R X 2: MANUFACTURING CODE -EWIPD; MANUFACTURE DATE IS 2012. MODERATE RUST COLORED STAINING IN THE BOX LOCK. NO SIGNS OF PRIOR REPAIR (TAPE MARKS). MANUFACTURING CODE -GVUEX; MANUFACTURE DATE IS 2014. HEAVY RUST COLORED STAINING IN THE BOX LOCL. NO SIGNS OF PRIOR REPAIR (TAPE MARKS). EVALUATION OF THE DEVICES INDICATES NO IMPROPER REPAIR OR MATERIAL OR MANUFACTURING DEFECTS PRESENT. STAINING CAN BE ATTRIBUTED TO IMPROPER CARE AND HANDLING DUE TO INADEQUATE WATER QUALITY AND / OR CROSS CONTAMINATION OF METALS. NO CORRECTIVE / PREVENTIVE ACTION IS REQUIRED.