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It was reported by the sales rep via phone that during an acl procedure with the customer's restore full flute reamer 7 mm and restore full flute reamer 8 mm.They had the tibial guide pin in place and it was time to ream the tibia to create our 8 mm tunnel.The doctor had the 8 mm fluted reamer chucked up and slid over the guide wire to engage the tibia.He began drilling and engaged the tibial cortex with the reamer.The reamer was spinning on the tibial cortex and the doctor was pushing harder than he normally has to push to break the near cortex.The reamer continued to spin without making advancement and now began smoking.At this point he stopped what he was trying to do and asked for a smaller fluted reamer, thinking that maybe the 8 mm fluted was dull (we use these reamers for every acl).The surgical tech loaded a 7 mm fluted reamer and they repeated the exact same steps and experienced the same results.The reamer spinning on the cortex, not making advancement, and smoking heavily.Once he came off with this reamer we noticed quite a few metal shavings and the area around the guide pin where the reamer was spinning was colored black (guessing from where the reamer was spinning and smoking).Now they were all perplexed and that¿s when we noticed that the distal end of the reamers were worn down and the cannulation hole was bigger than normal.They assumed the metal shavings that were created and in the field came from the distal tip of the reamers that were worn down.The procedure was completed with an 8 mm acorn reamer with no patient harm but there was a 2-3 minute surgical delay.The sales rep stated that the metal shavings were flushed out of the joint space with the water from the pump.The sales rep could not provide any lot numbers for the devices but the devices will be returning for evaluation.
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The complaint device was received and evaluated.Visual observation reveals the laser markings are slightly faded and the devices appear worn.The complaint of dull cutting edges can be confirmed.Also,the tip of the device seems to be chipped/shaved and those metal shavings were seems to be broken during the procedure as mentioned.The root cause for the device being chipped/shaved can be attributed to user handling of the device during the procedure.From the appearance of the device, it can be determined that this device is likely old and has seen heavy use.Therefore, the root cause of the dull edges is likely wear of the device over time due to repeated use.Furthermore, no lot numbers were provided which precludes in conducting manufacturing record evaluation.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.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.
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