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The following was provided in the initial report.The initial report received on 7/18/2019 by the end user was that the surgeon was having difficulty keeping screws on the screwdriver and drilling the screws into bone.At this time it was only reported that the issues the surgeon was having, "may cause a retain of foreign body," and "may cause a problem in recraniotomy.After requesting additional information, it was on (b)(6) 2019 that the end user specified the patient suffered "injury, bleeding, and bone fracture." it was unclear if the patient recovered, if an explant was required, what products or lots were being used.No testing could be completed and no investigation could be conducted, because bioplate offers multiple lines of self drilling and self tapping screws.Without a product code, or lot number, there is no way to confirm if there was actually any issue or if the surgeon was using the devices incorrectly.It could not be specifically confirmed if the products were even bioplate products.Follow up information: prior to receiving the samples, bioplate received additional information from the customer on 10/08/2019.It was stated that dr.(b)(6) failed to hold the screw by the blade, and as a result, placed bone wax on the tip of the blade to make it sticky.After this, the screw slipped while drilling.This additional information provides a clear explanation regarding how the patient may have been injured during the procedure as was reported in mdr 1000518793-2019-00001.This information was not known at the time of the reported incident.The ifu d156 rev.K that is provided with every bioplate product states the following: "10.0 the screwdriver blades must be replaced periodically.Each screwdriver blade has a gold colored coating on the tip.Any appearance of silver on the tip of the blade indicates that the blade has worn and must be replaced.Once the blade has worn, correct insertion of the screws may not be possible.11.0 it is recommended that the lp (low profile) cross drive screws are only engaged once onto the driver blade.Thus lp cross drive screws that are engaged onto a blade and not used may be removed and discarded." the screws returned from the customer were in fact low profile screws.It is unknown how many times the screws were engaged onto the blade, but if the screw did not remain on the end of the blade even once, it is advised to discard the screw.The ifu does not state acceptable practice is to place bone wax on the tip of the blade and try again.In total, two containers were returned, complete with two sets of low profile plates and low profile screws.It appears of the two sets, a total of 10 screws may have been missing or used in previous cases.In addition to the containers, plates and screws, there were three cross drive screwdriver blades also returned.These blades originated from lots 201102230007, 201202240003, and 201708070002.Visually inspecting all three blades revealed that some level of gold coating had been removed.The physical condition of both the 2011 and 2012 blades indicated some form of physical damage on the blade tips.The 2017 blade appeared to be in the best condition with only minor wear of the gold coating.As reported on (b)(6) 2019, the blade used during the procedure was from lot 201202240003.Evident from the visual inspection, the 2012 blade contained the most damage.This may have been caused by the surgeon during the procedure or may have existed prior to the procedure and attributed to the difficulty keeping the screw on the blade.It was not reported what lot number or length of screw was being used during the procedure.Therefore, 2 examples were taken from each container and each size.The slot width was taken from two places on each screw.The data is provided below.Screw: specification: measurement #1 measurement #2: pass/fail: container 1: 3mm #1, 0.0215" - 0.0230", 0.0226", 0.0227", pass.Container 1: 3mm #2, 0.0215" - 0.0230", 0.0220", 0.0221", pass.Container 1: 4mm #1, 0.0215" - 0.0230", 0.0225", 0.0227", pass.Container 1: 4mm #2, 0.0215" - 0.0230", 0.0230", 0.0229", pass.Container 1: 5mm #1, 0.0215" - 0.0230", 0.0223", 0.0225", pass.Container 2: 5mm #2, 0.0215" - 0.0230", 0.0223", 0.0229", pass.Container 2: 3mm #1, 0.0215" - 0.0230", 0.0218", 0.0219", pass.Container 2: 3mm #2, 0.0215" - 0.0230", 0.0219", 0.0219", pass.Container 2: 4mm #1, 0.0215" - 0.0230", 0.0217", 0.0218", pass.Container 2: 4mm #2, 0.0215" - 0.0230", 0.0228", 0.0229", pass.Container 2: 5mm #1, 0.0215" - 0.0230", 0.0217", 0.0222", pass.Container 2: 5mm #2, 0.0215" - 0.0230", 0.0215", 0.0216", pass.The specification for the slot width of a low profile screw is 0.0220" + 0.010" or -0.005" with a total specification range of 0.0215" to 0.0230." while still in specification, any screw exhibiting measurements near the upper range of the tolerance could feasibly fall off of the blade if the screwdriver blade is worn already.It was also noticed through inspection that many of the screws above contained damage to the slots in the screw head.Being that these are new, unused screws, the heads should contain no damage whatsoever.Based on these findings, the most likely root cause is related to user error; both failing to remove worn screwdriver blades from circulation and from the surgeon applying bone wax to a screw to encourage it to stick to the screwdriver blade.Finally, an additional cause that may have contributed to the surgeons difficulty of applying a screw to the blade was pre-existing damage to the screw heads.Bioplate does not insert a blade in the screw heads at any time during inspection or manfacturing.If the end user's facility used a screwdriver blade to load the screws into the sterilization container, the slots on the heads of the screwdriver could have been damaged causing the slot widths to register outside of the acceptable specification range.The ifu states that screws should not be re-engaged once already engaged onto a screwdriver.
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On (b)(6) 2019, dr.(b)(6) reported the screwdriver is not holding the screws.The doctor stated the screws were too small to trace if they go missing during surgery and may cause retention of a foreign body in the patient.The doctor also stated the self drilling screws are not drilling and that extra force is required to apply the screws.The extra force may cause the screws to break which would cause a problem during the re-craniotomy.This initial report did not state any patient was injured.Bioplate requested more information to determine if any patients were affected and to gather more information about which products and lots were being used during the cases.On (b)(6) 2019 the doctor replied with the following statement that the patient suffered, "bleeding, injury, bone fracture." he also said, "the bioplate system was rigid.Hard to use, need force to be pushed.Stripped in two occasion.It harm the patient." no additional information was provided regarding medical intervention, outcome of the patient, or product information such as item codes or lot numbers.This complaint occurred outside the united states in saudi arabia.On 9/1/2019, the customer provided the item code and lot number of the screwdriver.The item code was 81-5751 with lot number 201202240003.No information was provided about the actual screws that were being used at the time of the incident.Follow up information: on 10/08/2019, bioplate's distributor provided more information regarding this incident.(b)(6) informed that when dr.(b)(6) failed to hold the screw by the blade, they put a bone wax on the tip of the blade to make it sticky, after this the screw slipped while drilling.On 10/14/2019, bioplate received the devices for investigation.The screws received were loose in the container and no lot or product code information was available.The screws returned were gold anodized 1.5mm self drilling screws in lengths 3mm, 4mm, and 5mm.The screwdrivers returned had the following lot numbers; 201102230007, 201202240003, and 201708070002.
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