SALVATION
Received May 24, 2021 · Event occurred Apr 27, 2021
Report 0001043534-2021-00088 · MDR key 11873481
Device
Generic name
Bit, Surgical
Manufacturer
Wright Medical Technology, Inc.Model number
SB080045Catalog number
SB080045
Lot number
UNKNOWN
Product problems
- Break
- Break
Patient
46 YR
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT THE STEP DRILL BIT BROKE OFF IN THE PATIENT'S METATARSAL. IT SNAPPED AT THE SITE WHERE THE STEP OF THE DRILL IS. LOCATED. THERE WAS A 20 MINUTE DELAY TO THE SURGERY AS THE SURGEON MADE A SMALL INCISION POSTERIOR NEAR THE ACHILLES TO RETRIEVE THE DRILL BIT PIECE. ALL FRAGMENTS WERE REMOVED.
Description of Event or Problem
IT WAS REPORTED THAT THE STEP DRILL BIT BROKE OFF IN THE PATIENT'S METATARSAL. IT SNAPPED AT THE SITE WHERE THE STEP OF THE DRILL IS. LOCATED. THERE WAS A 20 MINUTE DELAY TO THE SURGERY AS THE SURGEON MADE A SMALL INCISION POSTERIOR NEAR THE ACHILLES TO RETRIEVE THE DRILL BIT PIECE. ALL FRAGMENTS WERE REMOVED.
Additional Manufacturer Narrative
THE REPORTED EVENT COULD BE CONFIRMED, SINCE IMAGES WERE PROVIDED. INSPECTION OF THE PROVIDED IMAGES CONFIRMS THE TIP OF THE DRILL IS DEFORMED AND HAS FRACTURED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. THE IFU INSTRUCTS THE USER THAT: "INSPECT DEVICES PRIOR TO USE FOR DAMAGE DURING SHIPMENT OR STORAGE OR ANY OUT-OF-BOX DEFECTS THAT MIGHT INCREASE THE LIKELIHOOD OF FRAGMENTATION DURING A PROCEDURE" AND "SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FROM PROLONGED USE, AND THROUGH MISUSE OR ROUGH HANDLING¿. THE PACKAGE INSERT ALSO PROVIDES THE FOLLOWING RECOMMENDATION RELATING TO DEVICE FRAGMENTS, "CAREFULLY CONSIDER AND DISCUSS WITH THE PATIENT (IF POSSIBLE) THE RISKS AND BENEFITS OF RETRIEVING VS. LEAVING THE FRAGMENT IN THE PATIENT.¿ A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.