IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø8,0X480MM

Additional Manufacturer Narrative

ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

DURING INCOMING INSPECTION OF THE DEVICE IT WAS NOTICED THAT THE ITEM WAS DAMAGED.

Additional Manufacturer Narrative

REFERRING TO THE PRODUCT INQUIRY THE IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø8,0X480MM IS THE ONLY REPORTED DEVICE AND THUS CONSIDERED THE PRIMARY PRODUCT. AS THE REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DISCREPANCIES, WE EXCLUDE DEVIATIONS IN MATERIAL AND MANUFACTURING. ALTHOUGH REPEATEDLY REQUESTED THE AFFECTED REAMER WAS NOT RETURNED FOR EVALUATION TO DATE (AFTER 108 DAYS). LIKEWISE, NO INFORMATION REGARDING THE LOCATION OF DAMAGE WAS PROVIDED ON REQUEST. IN ABSENCE OF THE DEVICE IN QUESTION AND ONLY BASED ON THE MINIMAL INFORMATION PROVIDED THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. REVIEW OF COMPLAINT HISTORY, CAPA DATABASES AND RISK ANALYSIS DID NOT IDENTIFY ANY CONSPICUITY. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS ADDRESSED ADEQUATELY. THERE ARE NO OPEN ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT. NO NON-CONFORMITY WAS IDENTIFIED.

Description of Event or Problem

DURING INCOMING INSPECTION OF THE DEVICE IT WAS NOTICED THAT THE ITEM WAS DAMAGED.

Additional Manufacturer Narrative

REFERRING TO THE PRODUCT INQUIRY THE IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø8,0X480MM IS THE ONLY REPORTED DEVICE AND THUS CONSIDERED THE PRIMARY PRODUCT. AS THE REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DISCREPANCIES, WE EXCLUDE DEVIATIONS IN MATERIAL AND MANUFACTURING. INITIALLY, THE REPORTED IM REAMER WAS NOT RETURNED FOR EVALUATION. NEVERTHELESS, 4 WEEKS AFTER INVESTIGATION CLOSURE (AFTER 109 DAYS IN TOTAL) THE REAMER WAS RECEIVED AT STRYKER (B)(4). THE INVESTIGATION WAS RE-OPENED. THE SPIRAL (OUTER AND INNER) OF THE IM REAMER RECEIVED IS SIGNIFICANTLY BENT UP TO APPROXIMATELY 45 DEGREES. THE APPEARANCE OF DAMAGE REVEALS THAT THE ROOT CAUSE OF THE REPORTED EVENT IS NOT DEVICE RELATED, BUT IS RATHER CLEARLY LINKED TO ABNORMAL USE (UNREASONABLY ROUGH HANDLING OF MEDICAL DEVICES). THIS MASSIVE KINK AT THE FIRST WINDING OF THE SPIRAL DID NOT OCCUR DURING USE BUT WAS RATHER CAUSED UNREASONABLY, WHICH IS SUPPORTED BY THE FACT THAT THE SURFACES AND CUTTING EDGES OF THE REAMER HEAD, THE ADAPTER AND THE SPIRAL DON¿T SHOW ANY TRACES OF USAGE. APART FROM THAT, IN THIS CONDITION IT IS NO MORE POSSIBLE TO INSERT RESPECTIVELY TO REMOVE A GUIDE WIRE, WHICH REVEALS THAT THE BEND WAS ORIGINATED WITHOUT AN INSERTED GUIDE WIRE. REVIEW OF COMPLAINT HISTORY, CAPA DATABASES AND RISK ANALYSIS DID NOT IDENTIFY ANY CONSPICUITY. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS ADDRESSED ADEQUATELY. THERE ARE NO ACTIONS IN PLACE RELATED TO THE EVENT FOR THE SUBJECT PRODUCT. A REVIEW OF THE LABELLING DID NOT INDICATE ANY ABNORMALITIES. NO NON-CONFORMITY WAS IDENTIFIED.

Description of Event or Problem

DURING INCOMING INSPECTION OF THE DEVICE IT WAS NOTICED THAT THE ITEM WAS DAMAGED.

Additional Manufacturer Narrative

REFERRING TO THE PRODUCT INQUIRY THE IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø8,0X480MM IS THE ONLY REPORTED DEVICE AND THUS CONSIDERED THE PRIMARY PRODUCT. AS THE REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DISCREPANCIES, WE EXCLUDE DEVIATIONS IN MATERIAL AND MANUFACTURING. ALTHOUGH REPEATEDLY REQUESTED THE AFFECTED REAMER WAS NOT RETURNED FOR EVALUATION TO DATE (AFTER 108 DAYS). LIKEWISE, NO INFORMATION REGARDING THE LOCATION OF DAMAGE WAS PROVIDED ON REQUEST. IN ABSENCE OF THE DEVICE IN QUESTION AND ONLY BASED ON THE MINIMAL INFORMATION PROVIDED THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. REVIEW OF COMPLAINT HISTORY, CAPA DATABASES AND RISK ANALYSIS DID NOT IDENTIFY ANY CONSPICUITY. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS ADDRESSED ADEQUATELY. THERE ARE NO OPEN ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT. NO NON-CONFORMITY WAS IDENTIFIED.

Description of Event or Problem

DURING INCOMING INSPECTION OF THE DEVICE IT WAS NOTICED THAT THE ITEM WAS DAMAGED.