LOW PROFILE REAMER, 11MM

Report

Report Number: 1221934-2023-00768
Event Type: Malfunction
Date Received: February 15, 2023
Date of Event: January 30, 2023
Manufacturer: DEPUY MITEK LLC US
Product Code: HTO
UDI-DI: 10886705024315
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NM, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. : INVESTIGATION SUMMARY: THE COMPLAINT DEVICES HAVE NOT BEEN RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. HOWEVER, PHOTOS WERE PROVIDED. UPON VISUAL INSPECTION OF THE PHOTOS, THE DEVICES WERE OBSERVED IN A STERILIZATION TRAY AND NOT IN ITS ORIGINAL PACKAGING. UNDER MAGNIFICATION, ONE PHOTO SHOWED EVIDENCE OF CONTAMINATION IN THE CANAL. IT IS UNKNOW WHICH PRODUCT WAS OBSERVED IN THE PHOTO. THIS COMPLAINT CAN BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 2201001, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PHOTOS DO NOT PROVIDE ENOUGH EVIDENCE TO DETERMINE ROOT CAUSE. PHYSICAL EVALUATION IS REQUIRED TO PROVIDE MORE INFORMATION TO DISCERN A POSSIBLE ROOT CAUSE. AS PER IFU, THE PRECAUTIONS FOR THIS TYPE OF DEVICE CONSIST OF TO INSPECT THE CONDITION OF THE DEVICE PRIOR TO USE. FOR THE INSTRUMENT LIFE, IT IS NECESSARY TO FOLLOW THE INSTRUCTIONS AND WARNINGS OF ANY CLEANING AND DISINFECTION AGENTS AND EQUIPMENT USED; ALSO, THE RECOMMENDATION OF THE PROPER CONDITION DURING THE STERILIZATION AND MAINTENANCE TO AVOID ANY DAMAGE. FOLLOW THE INSTRUCTIONS AND WARNINGS ISSUED BY THE SUPPLIERS OF ANY CLEANING AND DISINFECTION AGENTS AND EQUIPMENT USED. AVOID EXPOSING INSTRUMENTS TO HYPOCHLORITE SOLUTIONS, AS THESE WILL PROMOTE CORROSION. AVOID PROLONGED EXPOSURE TO SALINE TO MINIMIZE THE CHANCE OF CORROSION. PRIOR TO STERILIZATION, INSTRUMENTS SHOULD BE CLEANED BY EITHER AUTOMATED OR MANUAL MEANS DESCRIBED BELOW. DRY THE INSTRUMENT IMMEDIATELY AFTER FINAL RINSE. USE FILTERED COMPRESSED AIR TO DRY INTERNAL AREAS. AFTER DRYING PROCEED TO INSPECTION INSTRUCTIONS. INSPECT ALL INSTRUMENTS BEFORE STERILIZATION OR STORAGE TO ENSURE THE COMPLETE REMOVAL OF SOIL FROM SURFACES, TUBES AND HOLES, MOVEABLE PARTS. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO MONITOR ADDITIONAL COMPLAINT INFORMATION FOR POTENTIAL SAFETY SIGNALS THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

Additional Manufacturer Narrative · 0

THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: UDI: (B)(4). THE EXPIRATION DATE IS CURRENTLY UNAVAILABLE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

Additional Manufacturer Narrative · 0

THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY : THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. UPON VISUAL INSPECTION, THE DEVICE HAS NO STRUCTURAL ANOMALIES OR DAMAGES. UNDER MAGNIFICATION INTO THE CENTER CANAL, NO CONTAMINATION OR OTHER TYPE OF MATTER WAS FOUND INSIDE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 2201001, AND NO NON-CONFORMANCES WERE IDENTIFIED. ACCORDING WITH THE PHYSICAL INSPECTION RESULT, THIS COMPLAINT CANNOT BE CONFIRMED. AS PER IFU, THE PRECAUTIONS FOR THIS TYPE OF DEVICE CONSIST OF TO INSPECT THE CONDITION OF THE DEVICE PRIOR TO USE. FOR THE INSTRUMENT LIFE, IT IS NECESSARY TO FOLLOW THE INSTRUCTIONS AND WARNINGS OF ANY CLEANING AND DISINFECTION AGENTS AND EQUIPMENT USED; ALSO, THE RECOMMENDATION OF THE PROPER CONDITION DURING THE STERILIZATION AND MAINTENANCE TO AVOID ANY DAMAGE. FOLLOW THE INSTRUCTIONS AND WARNINGS ISSUED BY THE SUPPLIERS OF ANY CLEANING AND DISINFECTION AGENTS AND EQUIPMENT USED. AVOID EXPOSING INSTRUMENTS TO HYPOCHLORITE SOLUTIONS, AS THESE WILL PROMOTE CORROSION. AVOID PROLONGED EXPOSURE TO SALINE TO MINIMIZE THE CHANCE OF CORROSION. PRIOR TO STERILIZATION, INSTRUMENTS SHOULD BE CLEANED BY EITHER AUTOMATED OR MANUAL MEANS DESCRIBED BELOW. DRY THE INSTRUMENT IMMEDIATELY AFTER FINAL RINSE. USE FILTERED COMPRESSED AIR TO DRY INTERNAL AREAS. AFTER DRYING PROCEED TO INSPECTION INSTRUCTIONS. INSPECT ALL INSTRUMENTS BEFORE STERILIZATION OR STORAGE TO ENSURE THE COMPLETE REMOVAL OF SOIL FROM SURFACES, TUBES AND HOLES, MOVEABLE PARTS. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHESE MITEK WILL CONTINUE TO MONITOR ADDITIONAL COMPLAINT INFORMATION FOR POTENTIAL SAFETY SIGNALS THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

Additional Manufacturer Narrative · 0

THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. D9, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 0

THIS IS REPORT 16 OF 28 FOR (B)(4). IT WAS REPORTED BY THE FIELD SERVICE ENGINEER THAT DURING INSPECTION, THE CUSTOMER OBSERVED THAT THE LOW PROFILE REAMER, 11MM DEVICE HAD CONTAMINATION INSIDE ITS CANNULATED SECTION. ACCORDING TO THE REPORT, THE EVENT OCCURRED BEFORE PROCESSING WHEN THE CUSTOMER DECIDED TO INSPECT THE DEVICE WITH THEIR BORESCOPE. IT WAS REPORTED THAT THE DEVICE WAS PURCHASED ON (B)(6) 2022; AND HAS NEVER BEEN USED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS SHELVED AND STORED IN CONTROLLED ENVIRONMENT IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1140755	LOW PROFILE REAMER, 11MM	CANNULATED SURGICAL DRILL	HTO	DEPUY MITEK LLC US	219634	2201001	10886705024315

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown