MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-12-04 for SINGLE USE 8MM SCRAPER PROBE - 80MM - STERILE OHS2080SU manufactured by Orthofix Srl.
[129154249]
Analysis of historical records orthofix (b)(4) checked the internal records related to the controls made on the device code ohs2080su, lot b1255002 before the market release. No anomalies have been found. The original lot, manufactured in 2018, 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. Technical evaluation: the device involved in this event has not been received at orthofix (b)(4) yet. The technical evaluation will be performed once the device is returned. 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.
Patient Sequence No: 1, Text Type: N, H10
[129154250]
The information provided by the local distributor indicates: hospital name: (b)(6); surgeon's name: dr. (b)(6); date of surgery: (b)(6) 2018; body part to which device was applied: femur; patient information: (b)(6) year-old, female, previous health condition: intervention on pth problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem; event description: (b)(6)-year-old patient managed for pth revision for stem loosening. The ablation of the cement is carried out with the oscar ablation system from orthofix. The device "scrapper probe" broke in the femur of the patient. The head of the device remained stuck in the femoral shaft. The complaint report form also indicates: the device failure had adverse effects on patient: longer intervention time. Risk of having to perform a femorotomy if the head of the device could not be removed. The surgery was not completed with the device. The event led to a clinically relevant increase in the duration of the surgical procedure: longer intervention time. An additional surgery was not required. A medical intervention (outpatient clinic) was not required. Copies of the operative reports are not available. Copies of the x-ray images are not available. On (b)(4) 2018, the local distributor provided a copy of x-ray images taken on (b)(6) 2018 and the following further information: patient's weight and height: (b)(6). Prolongation of surgery time: 30 min. The head of the probe had been put off with hard conditions. Patient's current health condition: post operative situation has been simple and patient went out from hospital by (b)(6) 2018. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680825-2018-00099 |
| MDR Report Key | 8127902 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-12-04 |
| Date of Report | 2019-02-28 |
| Date of Event | 2018-10-31 |
| Date Mfgr Received | 2019-02-18 |
| Device Manufacturer Date | 2018-08-07 |
| Date Added to Maude | 2018-12-04 |
| 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 | SINGLE USE 8MM SCRAPER PROBE - 80MM - STERILE |
| Generic Name | SINGLE USE 8MM SCRAPER PROBE - 80MM - STERILE |
| Product Code | JDX |
| Date Received | 2018-12-04 |
| Returned To Mfg | 2019-01-02 |
| Model Number | OHS2080SU |
| Catalog Number | OHS2080SU |
| Lot Number | B1255002 |
| 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 | 1. Required No Informationntervention | 2018-12-04 |