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Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device code ohs2080su lot b1116376 (lot marked on the component is g003) before the market release.No anomalies have been found.The original lot, manufactured in 2017, was comprised of (b)(4) devices.All of them have already been released to the market.According to orthofix (b)(4) historical records, this is the first notification received from this specific device lot (mfr report 9680825-2018-00023).Orthofix (b)(4) checked the internal records related to the controls made on the device code ohs2080su lot g001 before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of (b)(4) devices.All of them have already been released to the market.According to orthofix (b)(4) historical records, this is the first notification received from this specific device lot (this mfr report).Technical evaluation the technical evaluation on the returned devices, received on march 13, 2018, is currently on going.Medical evaluation the information available on the case was sent to our medical evaluator.A preliminary medical evaluation was performed and will be finalized once the results of the technical investigation are available.As soon as the results of the investigation become available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.Please also kindly refer to mfr report 9680825-2018-00023.
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The information initially provided by the local distributor indicates: "two probes used within patient femur snapped in half during the process, surgeon has provided photos which will be attached with complaint form.Surgery delayed by 30 mins.Waiting on further information from hospital regarding collection of probes.As yet the model number and serial number have not been obtained".On march 6, 2018, orthofix (b)(4) received the following information from (b)(6): hospital name: (b)(6) hospital.Consultant in charge: mr (b)(6).Incident (b)(4).Type of injury: none.Catalogue number: ohs2080su.Lot or batch number: b1116376.Date of manufacture: 21 jun 2017.Expiry date: 21 may 2022.Date of incident: (b)(6) 2018.Details of incident: while surgeon was clearing the cement from femur using oscar 2, 8 mm scraper single use probe suddenly broke and got stuck inside femur.Used new probe same description and continue to clear the cement but second probe also broke again.Details of injury: oscar probe was broken inside the femur, the broken tip was retrieved.No harm caused to the patient.It caused stress to the surgeon and scrub nurse.Action taken: discontinued using the probe.(b)(4).Please also kindly refer to mfr report 9680825-2018-00023.
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The information initially provided by the local distributor indicates: "two probes used within patient femur snapped in half during the process, surgeon has provided photos which will be attached with complaint form.Surgery delayed by 30mins.Waiting on further information from hospital regarding collection of probes.As yet the model number and serial number have not been obtained".On march 6, 2018, orthofix srl received the following information from mhra: hospital name: (b)(6) hospital.Consultant in charge: (b)(6) incident number: (b)(4).Type of injury: none.Catalogue number: ohs2080su.Lot or batch number: b1116376.Date of manufacture: 21 jun 2017.Expiry date: 21 may 2022.Date of incident: (b)(6) 2018.Details of incident: while surgeon was clearing the cement from femur using oscar 2, 8mm scraper single use probe suddenly broke and got stuck inside femur.Used new probe same description and continue to clear the cement but second probe also broke again.Details of injury: oscar probe was broken inside the femur, the broken tip was retrieved.No harm caused to the patient.It caused stress to the surgeon and scrub nurse.Action taken: discontinued using the probe.Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).Please also kindly refer to mfr report 9680825-2018-00023.
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On july 2017 orthofix srl acquired from orthosonics ltd, the oscar system, for ultrasonic arthroplasty revision.Therefore, orthofix srl is now managing post-market surveillance for oscar devices, also for the ones manufactured and released to the market by orthosonics ltd.Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code ohs2080su lot b1116376 (lot marked on the component is g003) before the market release.No anomalies have been found.The original lot, manufactured in 2017, was comprised of 39 devices.All of them have already been released to the market.According to orthofix srl historical records, this is the first notification received from this specific device lot.Orthofix srl checked the internal records related to the controls made on the device code ohs2080su lot g001 before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of 273 devices.All of them have already been released to the market.According to orthofix srl historical records, this is the first notification received from this specific device lot.Technical evaluation: the returned devices, received on march 13th, 2018, were examined by orthofix srl quality engineering department.The returned devices were subjected to visual and dimensional check as per orthofix srl specification and then sent to an external laboratory for the raw material check and failure analysis.1) device code ohs2080su lot g003 (label lot b1116376) - mfr report 9680825-2018-00023: the visual check evidenced that the single use 8mm scraper probe is broken at about 43,8 mm from thread bottom.The tip of the device showed presence of residuals (cement).The dimensional check, performed where possible as the device is broken, did not evidence any anomalies.The analysis of the raw material, performed by an external laboratory, confirmed that the item is in conformity with orthofix specifications.The fractographic clues indicate a unidirectional bending fatigue fracture, with origin in correspondence of laser marking.It is plausible that a crack due to the stresses acting on the probe (ultrasound or manual stresses) was propagated causing the breakage.We may suppose that there was a case-specific factor contributing to the breakage, such as the accidental contact with hard materials during clinical use.2) device code ohs2080su lot g001 - mfr report 9680825-2018-00024: the visual check evidenced that the single use 8mm scraper probe is broken at about 46,5 mm from thread bottom.No other visual anomalies were detected.The dimensional check, performed where possible as the device is broken, did not evidence any anomalies.The analysis of the raw material, performed by an external laboratory, confirmed that the item is in conformity with orthofix specifications.The fractographic clues indicate a unidirectional bending fatigue fracture, with origin in correspondence of laser marking.It is plausible that a crack due to the stresses acting on the probe (ultrasound or manual stresses) was propagated causing the breakage.We may suppose that there was a case-specific factor contributing to the breakage, such as the accidental contact with hard materials during clinical use.Medical evaluation: the information made available on the case together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluations performed.(b)(6) 2018: "the probes that broke in this case are both single use axisymmetric reverse scrapers.These are single use and as such have a "size and mass much reduced from the reusable probes" as stated in the operative technique os- 1501-opt.Occasional breakages might be expected.I assume that in this case both probes were broken in the same patient.The breakages occurred as the probe was being withdrawn.By the nature of the use of a scraper probe, these probes are withdrawn while holding the scraper tip against the side of the bone.It may well be that the lateral load on the probe contributed to the breakage, certainly if it was excessive.The problem as with all instruments is that it is designed to be used with reasonable force or loading, and the definition of excessive force is inevitably imprecise.It is stated that there was a 30 minute delay.I think that the delay could have been because the surgeon was retrieving the broken piece(s) of the probe, or because the theatre staff were fetching another probe".April 2, 2018 with the results of the technical evaluation: "the technical analysis of the failure of these two probes shows that the dimensions and material composition of the 2 probes is within specification.The morphology of the broken surface in each case suggests a unidirectional bending fatigue fracture, originating at a laser marking".Final comments: orthofix failure analysis can conclude that the damage occurred could be mainly attributable to stresses acting on the probes (ultrasound and manual stresses) that propagated from the laser marking, causing the breakage.We may suppose that there was a case-specific factor contributing to the breakage, such as the accidental contact with hard materials during clinical use.The analysis of the historical data evidenced that no other similar notifications have been received on devices belonging to the same lots.Orthofix srl continues monitoring the devices on the market.Please also kindly refer to mfr report 9680825-2018-00023.
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