MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-04-18 for GOTFRIED PC.C.P. NECK SCREW DRIVER 184000 manufactured by Orthofix Srl.
[142337051]
Technical evaluation: the device involved in this event has not yet been received by orthofix (b)(4). The technical evaluation will be performed as soon as the device becomes available. Medical evaluation: the information available on the case was sent to our medical evaluator. A preliminary medical evaluation is currently on going and will be finalized once the results of the technical evaluation and/or further information on the case are available. As soon as the results of the investigation are 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
[142337052]
The information provided by the local distributor indicates: hospital name: (b)(6). Surgeon's name: dr. (b)(6). Date of initial surgery: n/a. Body part to which device was applied: n/a. Surgery description: fracture treatment. Patient information: n/a. Problem observed during: clinical use on patient/intraoperative. Type of problem: functional problem. Event description: the inner shaft in the driver is too long and popping out without pushing the button on top thus its impossible to assemble/disassemble it after insertion. The complaint report form also indicates: the device failure had no adverse effects on patient. The initial surgery was not completed with the device. A replacement device was immediately available to complete surgery. The event led to a clinically relevant increase in the duration of the surgical procedure: 40 minutes delay. 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 condition: unknown. Further information received from the distributor on april 15, 2019: "regarding patient details, as far as i know the patient recovers and this issue didn't affect her at all. I don't have any details about her age or weight. " manufacturer reference number: (b)(4). Distributor reference number: n/a.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680825-2019-00025 |
| MDR Report Key | 8526211 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-04-18 |
| Date of Report | 2019-07-05 |
| Date Mfgr Received | 2019-07-03 |
| Date Added to Maude | 2019-04-18 |
| 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, 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 37012 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOTFRIED PC.C.P. NECK SCREW DRIVER |
| Generic Name | GOTFRIED PC.C.P. NECK SCREW DRIVER |
| Product Code | JDO |
| Date Received | 2019-04-18 |
| Model Number | 184000 |
| Catalog Number | 184000 |
| Lot Number | AD0528 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX SRL |
| Manufacturer Address | VIA DELLE NAZIONI, 9 BUSSOLENGO, VERONA, 37012 IT 37012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-18 |