The customer returned 3ea 36-1001 and 9ea 36-1002.The customer stated that the surgeon has been having problems with this device for the past year, however there is no specific details for each break.All twelve devices were evaluated to represent this complaint.It was confirmed that all twelve were broken in the same location where the jaws come together.It was also noted that all twelve device had rusting and corrosion along the entire device, but especially in the crevices.The point where the jaws meet is the weakest point of the device and will break if too much pressure is applied to the jaws.Additionally, the rusting and corrosion of the material can cause it to become more brittle and more likely to break when this pressure is applied.The root cause can be determined to be improper cleaning processes along with too much pressure applied to the jaws during use.There has been a total of (b)(4) sold of 36-1001 and (b)(4) sold of 36-1002.There has been one additional complaint recorded for 36-1001 for a similar occurrence in 2017 and two additional complaint recorded for 36-1002 for a similar occurrence in 2020.(b)(4).This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional information that is pertinent to the investigation, a follow up report will be submitted.
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