MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-02-13 for CEMENT REMOVAL HANDSET OH300/2 manufactured by Orthofix Srl.
[139066101]
On july 2017 orthofix (b)(4) acquired from orthosonics ltd, the oscar system, for ultrasonic arthroplasty revision. Therefore, orthofix (b)(4) is now managing post-market surveillance for oscar devices, also for the ones manufactured and released to the market by orthosonics ltd. The devices involved in this event were manufactured by orthosonics ltd. Technical evaluation: the returned devices, received on january 17, 2019, were examined by orthofix (b)(4) quality engineering department. All devices were subjected to visual and functional check as per orthofix (b)(4) specification. The visual check evidenced as follows: the ultrasonic generator, device code os3000 serial number (b)(4), did not show any anomalies (mfr report 9680825-2019-00003). One cement removal handset, device code oh300/2 serial number (b)(4), showed that the rear end cap and the silicone o-ring were not in their proper position (mfr report 9680825-2019-00008). The functional check evidenced as follows: the ultrasonic generator, device code os3000 serial number (b)(4) is functioning properly. The cement removal handset, device code oh300/2 batch 3h0190, is not functioning properly. The sealing is lost from the rear body seal. The generator shows the alert message: "poor feedback". The handset is not detected by the generator. The results of the technical evaluation concluded as follows: the ultrasonic generator, device code os3000 serial number (b)(4) is functioning properly. The failure found on the cement removal handset, device code oh300/2 batch 3h0190, is most likely attributable to water that entered inside the handset during cleaning and sterilization cycles. This occurred as a result of an unforeseen disassembly of the connector end cap during reprocessing. The silicone o-rings was therefore not in contact with the mating parts hence not providing necessary sealing. Medical evaluation: the information made available on the case together with the results of the technical investigation were sent to our medical evaluator. Please find below an extract of the medical evaluations performed. "i note that in this case the oscar generator functioned sufficiently well for the operation to be completed as planned, but extra time was required. The findings of the technical analysis are that the oscar generator is in complete working order with no faults or signs of damage. The returned cement removal handset shows a problem: the connector end cap has been loosened, so that the joint is visibly open and the o-ring will no longer provide a seal. I note that the conclusion of the technical report is that the handset failed because the connector end cap has been loosened at some stage during the servicing process. The failure of this joint should have been noticed on inspection after cleaning. I note that in the instructions for use leaflet, re: pq osc, there are clear instructions that the connector end cap must not be removed". Final comments on july 2017 orthofix (b)(4) acquired from orthosonics ltd, the oscar system, for ultrasonic arthroplasty revision. Therefore, orthofix (b)(4) is now managing post-market surveillance for oscar devices, also for the ones manufactured and released to the market by orthosonics ltd. The devices involved in this event were manufactured by orthosonics ltd. The results of the technical evaluation concluded as follows: the ultrasonic generator, device code os3000 serial number (b)(4) is functioning properly. The failure found on the cement removal handset, device code oh300/2 batch 3h0190, is most likely attributable to water that entered inside the handset during cleaning and sterilization cycles. This occurred as a result of an unforeseen disassembly of the connector end cap during reprocessing. The silicone o-rings was therefore not in contact with the mating parts hence not providing necessary sealing. The medical evaluation evidenced as follows: "i note that in this case the oscar generator functioned sufficiently well for the operation to be completed as planned, but extra time was required. The findings of the technical analysis are that the oscar generator is in complete working order with no faults or signs of damage. The returned cement removal handset shows a problem: the connector end cap has been loosened, so that the joint is visibly open and the o-ring will no longer provide a seal. I note that the conclusion of the technical report is that the handset failed because the connector end cap has been loosened at some stage during the servicing process. The failure of this joint should have been noticed on inspection after cleaning. I note that in the instructions for use leaflet, re: pq osc, there are clear instructions that the connector end cap must not be removed". Based on the results of the technical evaluation, which confirmed the ultrasonic generator conformity, an on the evidences deriving from the medical evaluation, orthofix (b)(4) can conclude that the problem that occurred is due to an incorrect reprocessing of the handset. Orthofix (b)(4) continues monitoring the devices on the market. Please also kindly refer to mfr report 9680825-2019-00003.
Patient Sequence No: 1, Text Type: N, H10
[139066102]
The information provided by the local distributor indicates: hospital name: (b)(6); surgeon name: (b)(6); date of surgery: no response; body part to which device was applied: hip; surgery description: revision surgery for the hip; problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem; event description: "poor frequency connection error message. Recently moved to single use probes. Used device for revision surgery of the hip, single use probe attached by experienced odp... Poor frequency error on console. We tried both ports and both hand pieces. Same issue occurred". The complaint report form also indicates: the device failure did not have any adverse effects to patient; the initial surgery was completed with the device; the event led to a clinically relevant increase in the duration of the surgical procedure (extra anaesthetic, longer surgical time); an additional surgery was not required; a medical intervention (outpatient clinic) was not required; copies of the operative report are not available; copies of the x-ray images are not available; note and comments: no patient information is relevant for this document. On january 3, 2019, orthofix (b)(4) received the following additional details: date of surgery was friday (b)(6) 2018. The extra time was approximately 30-45 minutes. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680825-2019-00008 |
| MDR Report Key | 8335067 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-02-13 |
| Date of Report | 2019-02-12 |
| Date of Event | 2018-12-28 |
| Date Mfgr Received | 2019-02-08 |
| Date Added to Maude | 2019-02-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERTO DONADELLO |
| Manufacturer Street | VIA DELLE NAZIONI, 9 |
| Manufacturer City | BUSSOLENGO, VERONA, ITALY 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal | 37012 |
| Manufacturer G1 | ORTHOFIX SRL |
| Manufacturer Street | VIA DELLE NAZIONI, 9 |
| Manufacturer City | BUSSOLENGO, VERONA, ITALY 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 37012 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEMENT REMOVAL HANDSET |
| Generic Name | CEMENT REMOVAL HANDSET |
| Product Code | JDX |
| Date Received | 2019-02-13 |
| Returned To Mfg | 2019-01-17 |
| Model Number | OH300/2 |
| Catalog Number | OH300/2 |
| Lot Number | 3H0190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX SRL |
| Manufacturer Address | VIA DELLE NAZIONI, 9 BUSSOLENGO, VERONA, ITALY 37012 IT 37012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-13 |