ALLOGRAFT EVANS WEDGE 10X22X20MM
Received Aug 9, 2016 · Event occurred Jan 28, 2016
Report 0009617544-2016-00324 · MDR key 5857780
Device
Generic name
Resorbable Calcium Salt Bone Void Filler Device
Manufacturer
Stryker Orthobiologics-malvernCatalog number
3102-1910
Lot number
153193-1011
Product problems
- Adverse Event Without Identified Device or Use Problem
- Device Handling Problem
- Adverse Event Without Identified Device or Use Problem
- Device Handling Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
METHOD: RISK ASSESSMENT; RESULTS: THERE IS NO DEVICE SPECIFIC FAILURE MODE IDENTIFIED WITH THE REPORTED DEVICE, THE ISSUE WAS WITH PROPER FACILITY TRANSFER PROTOCOL NOT BEING FOLLOWED. CONCLUSION: THE INVESTIGATION CONCLUDED THIS IS A COMPLIANCE ISSUE WITH THE PROPER HANDLING PROCESS OF TISSUE PRODUCTS AND THERE IS NO DEVICE SPECIFIC FAILURE MODE WITH THE REPORTED DEVICE.
Description of Event or Problem
IT WAS REPORTED THAT; PROTOCOL AT MEDICAL CENTER WAS NOT FOLLOWED FOR PROPER TRANSPORTATION OF BONE WEDGE BIOLOGIC GRAFT. THE REPRESENTATIVE PHYSICALLY BROUGHT IN THE GRAFT FROM A DIFFERENT FACILITY THAT HAD SHIPPED IN THE MORNING OF THE INCIDENT. THE GRAFT SHOULD HAVE BEEN SHIPPED IN DIRECTLY AND NOT BROUGHT IN FROM ANOTHER FACILITY. UPDATE: ON 27-JUL-2016; IT WAS REPORTED THE GRAFT WAS USED IN A PATIENT. FURTHERMORE, IT WAS REPORTED THE PATIENT IS DOING WELL AND NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED.
Additional Manufacturer Narrative
METHOD: IMPACT ASSESSMENT. DEVICE NOT RETURNED. RESULTS: DEVICE NOT RETURNED. THE SUPPLIED IMPACT ASSESSMENT STATED THAT BASED ON THE PACKAGING AND TEMPERATURE REQUIREMENTS FOR THE GRAFTS, THE MOVEMENT OF THE GRAFTS FROM ONE FACILITY TO ANOTHER WHILE MAINTAINED AT ROOM TEMPERATURE FOR THE STATED TIME DOES NOT CONFLICT WITH THE LABELED STORAGE CONDITIONS. CONCLUSION: THE INVESTIGATION CONCLUDED THIS IS A COMPLIANCE ISSUE WITH THE PROPER HANDLING PROCESS OF TISSUE PRODUCTS AND THERE IS NO DEVICE SPECIFIC FAILURE MODE WITH THE REPORTED DEVICE. IMPLANTED.
Description of Event or Problem
IT WAS REPORTED THAT: PROTOCOL AT MEDICAL CENTER WAS NOT FOLLOWED FOR PROPER TRANSPORTATION OF BONE WEDGE BIOLOGIC GRAFT. THE REPRESENTATIVE PHYSICALLY BROUGHT IN THE GRAFT FROM A DIFFERENT FACILITY THAT HAD SHIPPED IN THE MORNING OF THE INCIDENT. THE GRAFT SHOULD HAVE BEEN SHIPPED IN DIRECTLY AND NOT BROUGHT IN FROM ANOTHER FACILITY. UPDATE: ON (B)(6) 2016; IT WAS REPORTED THE GRAFT WAS USED IN A PATIENT. FURTHERMORE, IT WAS REPORTED THE PATIENT IS DOING WELL AND NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED.