MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-01-07 for ULTRASONIC GENERATOR 230V CE OS3000 manufactured by Orthofix Srl.
[132213854]
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 generator involved in this event was manufactured by orthosonics ltd. The handset was manufactured by orthofix (b)(4). Technical evaluation: during the technical evaluation it was evidenced that the generator returned was code ref. Os3000 instead of code ref. Oe3000b/2 as initially communicated by the distributor. In the material returned it was also found a defective handset, code ref. Oh300/2. The returned devices, received on december 6th, 2018, 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 did not evidence any anomalies. The functional check evidenced as follows: the ultrasonic generator, device code os3000 serial number (b)(4) is functioning properly: all the handsets were checked with the oscar generator linked with both the oscar cables; all the probes inside the loan set were checked with all the cement removal and the bonecutter handset; the electrical safety test has been performed, in particular pat test and leakage test were performed. All the checks passed. The cement removal handset, device code oh300/2 batch 3h4124, is not functioning properly. The switch cables have been detected tangled. The set screw inside the module is broken. This is due to an unusual rotation of the switch wires. 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. On 30 november 2018: in this case a male patient age not stated was having a prosthesis revision and cement removal. One of the 2 channels of the oscar system stopped working. There was a delay while the probe that was embedded in the cement was released, and the operation was concluded with only one channel. I can imagine that the operating time was extended further because of the need to change probes. The operation was concluded as planned, but the operation took 45 minutes extra time. This is significant in terms of theatre use, but there was no risk to the patient. On 27 december 2018 with the outcome of the technical investigation: this technical analysis makes it very clear that the cable that attaches the hand set to the generator has been twisted, presumably during connection. This has broken the set screw and twisted the cable which has then suffered a broken connection. This is the first time that this type of incident has happened with the hand set. The operators need to hold the connector and not the cable when connecting it. I agree that this breakage has occurred because of incorrect handling of the connecting cable. As far as we can tell from the complaint form, the breakage occurred during the operation so it was not possible to anticipate this event. Final comments: the results of the technical evaluation concluded as follows: the ultrasonic generator, device code os3000 serial number (b)(4) is functioning properly. All the tests performed passed. The failure found on the cement removal handset, device code oh300/2 batch 3h4124, related to tangled wires on the switch connector, is likely attributable to the incorrect position of the set screw that prevents the rotation. This may have happened during maintenance, after incorrect removal of the connector end cap (indication not to remove the end cap in leaflet pq osc, page 8). Based on the results of the technical evaluation, which confirmed the ultrasonic generator conformity, and on the evidences deriving from the medical evaluation, orthofix (b)(4) can conclude that the problem that occurred is due to incorrect removal of the connector end cap and internal components. Orthofix (b)(4) continues monitoring the devices on the market. (please kindly refer also to mfr report number 9680825-2018-00107). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[132213855]
The information provided by the local distributor indicates: hospital name: (b)(6). Surgeon name: mr. (b)(6)/mr. (b)(6). Date of initial surgery: (b)(6) 2018. Body part to which device was applied: femur. Surgery description: n/a. Patient information: male. Problem observed during: clinical use on patient/intraoperative. Event description: oscar probe became lodged in the femur while trying to remove cement. At the same time channel 1 on the generator was not working. Channel 2 had to be used and eventually the lodged oscar probe was released. The complaint report form also indicates: the device failure had no adverse effects on patient. The initial surgery was completed with the device. The event led to a clinically relevant increase in the duration of the surgical procedure: "surgery took longer due to trying to release the lodged probe and also only having one probe available instead of 2 due to channel 1 not working. It took approximately 45 mins to release probe and then delay with having to change probe ends during rest of surgery. " 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; patient current health conditions: procedure completed. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680825-2018-00106 |
| MDR Report Key | 8221793 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-01-07 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-11-12 |
| Date Mfgr Received | 2018-12-27 |
| Date Added to Maude | 2019-01-07 |
| 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 | ULTRASONIC GENERATOR 230V CE |
| Generic Name | ULTRASONIC GENERATOR 230V CE |
| Product Code | JDX |
| Date Received | 2019-01-07 |
| Returned To Mfg | 2018-12-06 |
| Model Number | OS3000 |
| Catalog Number | OS3000 |
| Lot Number | 3G029 |
| 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 | 1. Required No Informationntervention | 2019-01-07 |