OSTEO-SITE BONE BIOPSY NEEDLE

Additional Manufacturer Narrative

IT IS UNKNOWN IF THE REPORTER IS A HEALTH CARE PROFESSIONAL. PMA/510(K) #: EXEMPT THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

Description of Event or Problem

IT WAS REPORTED DURING A BIOPSY IN THE VERTEBRAE, ONE PRONG OF AN OSTEO-SITE BONE BIOPSY NEEDLE DETACHED AND REMAINS IN SITU. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE INITIAL DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DATE OF THE EVENT AND WHETHER THE PATIENT HAD ANY ANATOMICAL ANOMALIES. AT THIS TIME THE SALES REPRESENTATIVE HAS STATED THAT THE CUSTOMER DOES NOT WANT TO SHARE ANY PATIENT INFORMATION AND THE DATE OF THE EVENT REMAINS UNKNOWN. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

Description of Event or Problem

NO NEW INFORMATION TO ADD TO THE DESCRIPTION OF EVENT AT THIS TIME.

Additional Manufacturer Narrative

H6 - METHOD CODE: (4114) DEVICE NOT RETURNED. H6 - RESULTS CODE: (3252) FRACTURE PROBLEM. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. A REVIEW OF LOT INFORMATION BY THE SUPPLIER FOUND NO ISSUES OR GAPS IN QUALITY INSPECTION PROCEDURES. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT USER ERROR OR PATIENT ANATOMY CONTRIBUTED TO THIS FAILURE AS WELL. THE INNER STYLET IS GROUND FLUSH WITH THE OUTER CANNULA AND PROVIDES SUPPORT WHEN PIERCING BONE. IF THE DEVICE IS USED WITHOUT THE INNER STYLET, THE OUTER CANNULA PRONGS MAY BE MORE LIKELY TO BREAK. ALSO, EXCESSIVE FORCE ON THE DEVICE ONCE IT IS IN PLACE MAY CAUSE THE CANNULA TO BEND AND BREAK. WE HAVE NOTIFIED THE APPROPRIATE PERSONNEL. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.