KERRISON 15MM NOIR 130DEG UP 200MM 3MM
Received Jun 13, 2023 · Event occurred May 24, 2023
Report 2916714-2023-00079 · MDR key 17120064
Device
Product problems
- Physical Resistance/Sticking
- Physical Resistance/Sticking
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS (DHR) WERE NOT ABLE TO BE REVIEWED AS NO LOT NUMBER WAS MADE AVAILABLE. HOWEVER, ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. CONCLUSION AND MEASURES / PREVENTATIVE MEASURES: A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.
Description of Event or Problem
INVESTIGATION COMPLETE.
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED TO AESCULAP INC. THAT A KERRISON 15MM NOIR 130DEG UP 200MM 3MM (MATERIAL # FK982B) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE DEVICE BECAME STUCK AFTER TAKING A BONE BITE. REPORTEDLY, THE PHYSICIAN ENCOUNTERED PHYSICAL RESISTANCE WHILE ATTEMPTING TO ACTUATE THE HANDLE, WHICH REQUIRED HIM TO USE TWO (2) HANDS TO FORCIBLY RELEASE AND RETRIEVE THE BONE SPECIMEN. PRIOR TO TAKING THE BITE, THE HANDLE FUNCTIONED PROPERLY WITH SMOOTH ACTUATION NOTED. HOWEVER, AFTER TAKING THE BONE BITE, THE DEVICE JAMMED. ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY TO RETRIEVE THE DISLODGED BONE FRAGMENT. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).