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Patient 1
THE DEVICE WAS RECEIVED. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. INVESTIGATION SUMMARY INVESTIGATION SELECTION: INVESTIGATION SITE: (B)(4); SELECTED FLOW(S): 5. BROKEN. VISUAL INSPECTION: UPON VISUAL INSPECTION: WE HAVE RECEIVED SEVEN (7) SCREWS, THREE (3) 400.833 AND FOUR (4) 400.834, WITH NO LOT NUMBER REPORTED/PROVIDED FOR INVESTIGATION. EVERY SCREW HAS A BROKEN OFF TIP, JUST A BIT OF THE SHANK IS STILL VISIBLE ON THE SCREW HEAD (WE DO NOT KNOW WHERE THE MISSING PARTS ARE). FURTHERMORE, ALL RECESS'S SHOW SIGNS OF USAGE, A FEW ARE EVEN BADLY WORN. THIS THUS CONFIRMING THE COMPLAINT DESCRIPTION. DOCUMENT/SPECIFICATION REVIEW: NOT REQUIRED PER SELECTED INVESTIGATION FLOW, AS IT IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE. DIMENSIONAL INSPECTION: NOT REQUIRED PER SELECTED INVESTIGATION FLOW, AS IT IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE. MATERIAL OR HARDNESS REVIEW: NOT REQUIRED PER SELECTED INVESTIGATION FLOW, AS IT IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE. SUMMARY: THE RECEIVED CONDITION OF THE DEVICE IS CONCORDANT WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION IS CONFIRMED. UNFORTUNATELY, WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE, BUT WE HAVE TO ASSUME THAT DURING THE OPERATION AN APPLICATION ERROR MAY HAVE TAKEN PLACE OR/AND THAT DURING THE OPERATION EXCESSIVE FORCE (TOO MUCH MECHANICAL FORCE WHILST INSERTING INTO THE BONE) LED TO THIS DAMAGE. AS THESE SCREWS ARE VERY SMALL AND QUITE FRAGILE, A LOT OF CARE IS REQUIRED WHILE HANDLING. WE CAN CONFIRM THE VISIBLE DAMAGES ARE NOT FROM ANY MANUFACTURING NON-CONFORMITY. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.