UNKN TRAUMA & EXTREMITIES DEV

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE:(B)(4). ADDITIONAL INFORMATION: E1, E2, E3, H6 AND H11 (ROI). H11: THE DEVICES WERE NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. DRILL BIT SPECIFIC IDENTIFIERS WERE NOT PROVIDED. THEREFORE, AN EVALUATION OF THE MANUFACTURING RECORDS, COMPLAINT HISTORY REVIEW, RISK MANAGEMENT FILE AND PRIOR ACTIONS REVIEW COULD NOT BE PERFORMED. FOR THE DOUBLE ENDED DRILL GUIDE A REVIEW OF THE PRODUCTION ORDER DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY BASED ON THE HISTORICAL DATA REVEALED SIMILAR EVENTS FOR THE LISTED BATCH, THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCTS FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE DRILL BIT IS A SINGLE USE DEVICE, SURGICAL TECHNIQUE OR DAMAGE FROM MISUSE ARE LIKELY POTENTIAL FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT. THE DOUBLE ENDED DRILL GUIDE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE LIKELY POTENTIAL FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICES OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY.

Description of Event or Problem

IT WAS REPORTED THAT DURING A CLAVICLE FIXATION SURGERY, A DRILL SNAPPED OFF INSIDE ONE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE AND COLD WELDED, UNABLE TO REMOVE. NO PIECES LEFT IN PATIENT OR WOUND. ALL PIECES ACCOUNTED FOR. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, WITH AN EQUIVALENT S+N BACK UP. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: CASE-(B)(4). THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN RISKS WITH THE DEVICE ITSELF OR WITH ITS USE THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.