MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-01-30 for CEMENT REMOVAL HANDSET OH300/2 manufactured by Orthofix Srl.
[137000773]
In 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 items involved in this event were manufactured by orthosonics ltd. Technical evaluation: the technical evaluation of the devices involved, received on january 15, 2019, is currently on going. Medical evaluation: the information made 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 are available, orthofix (b)(4) will provide a follow up report. Orthofix (b)(4) continues monitoring the devices on the market. Please also kindly refer to mfr reports 9680825-2019-00004/00005/00007.
Patient Sequence No: 1, Text Type: N, H10
[137000774]
The information provided by the local distributor indicates: products code: three handsets code oh300/2 batches (b)(4) (mfr reports 9680825-2019-00004/00005) and one probe code and batch unknown (mfr report 9680825-2019-00007). Hospital name: (b)(6); surgeon name: mr. (b)(6); date of initial surgery: (b)(6) 2018; body part to which device was applied: hip; surgery description: other; patient information: n. A. Problem observed during: clinical use on patient/intraoperative. Type of problem: device functional problem. Event description: three handpieces not working (definitely not the generator at fault). One handpiece has broken probe stuck in thread. The complaint report form also indicated: the device failure did not have any adverse effects on patient. The initial surgery was not completed with the device. A replacement device was not immediately available to complete surgery (used an oscar 2 device to complete the surgery). The event led to a clinically relevant increase in the duration of the surgical procedure (hospital was unable to confirm the amount of delay). An additional surgery was not required. A medical intervention (outpatient clinic) was not required. Copies of the operative report are available (not received). Copies of the x-ray images are available (not received). Patient current health conditions: no response. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680825-2019-00006 |
| MDR Report Key | 8288470 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-01-30 |
| Date of Report | 2019-03-05 |
| Date of Event | 2018-12-19 |
| Date Mfgr Received | 2019-02-19 |
| Date Added to Maude | 2019-01-30 |
| 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 | 2019-01-30 |
| Returned To Mfg | 2019-01-15 |
| Model Number | OH300/2 |
| Catalog Number | OH300/2 |
| Lot Number | 3H0262 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-01-30 |