MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-06-13 for WIRE TENSIONER 18001 manufactured by Orthofix Srl.
[4588516]
The info provided by the local distributor indicates: hospital name: (b)(6); surgeon name: (b)(6); date of surgery: (b)(6) 2014; problem observed during: clinical use on pt/ intraoperative. Event description: it's not possible to tighten k-wires. K-wires slip through the device. The complaint report form indicates: the surgery was not completed with the device. A replacement device was not immediately available to complete the surgery (loan device from pmm was used the day after). On (b)(6) 2014, orthofix srl received the following add'l info on the event: the device malfunctioned during the surgery ((b)(6) 2014). As a replacement device was not immediately available, the surgery was abandoned and postponed to the day after (date of revision surgery (b)(6) 2014). Apart of the re-intervention, no adverse effects occurred (so far). No other info has been made available. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11965420]
Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device code 180001s lot b183 before the market release. No anomalies have been found. The original lot, manufactured in 2010, was comprised of 1 device which was assembled in the finished device code 18001 lot it974213 comprised of (b)(4) wire tensioners. According to orthofix (b)(4) historical records, no other notifications have been received in regards to the code 18001 lot it974213. Technical eval: the returned device, received on (b)(6) 2014, was examined by orthofix (b)(4) quality engineering department. The device was subjected to visual and functional check as per orthofix (b)(4) design and product specs. The visual check did not evidence any anomalies. The functional check, performed using an internal specific instrumentation, evidenced that the returned device can function as intended. The results of the technical eval evidenced that the returned device still performs properly. The problem notified may be attributed to organic residuals occluding the cannulation. Medical eval: the info available on the case was sent to our medical evaluator. A preliminary medical eval was performed and will be finalized once further info on the event is available. Mfr's comments: orthofix has requested further info on the event to finalize the medical eval such as pt info (age, sex, weight and diagnosis), copies of the operative reports (initial surgery and revision one), copies of the pre and post-operative x-rays (initial surgery and revision one), picture of the frame application and info on pt current health condition. Unfortunately, this info has not yet made available. As soon as further info is available, orthofix (b)(4) will provide you with a f/u report. Orthofix (b)(4) continues monitoring the devices on the market.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680825-2014-00016 |
| MDR Report Key | 3908045 |
| Report Source | 01,08 |
| Date Received | 2014-06-13 |
| Date of Report | 2014-06-12 |
| Date of Event | 2014-05-11 |
| Date Mfgr Received | 2014-05-16 |
| Device Manufacturer Date | 2010-02-01 |
| Date Added to Maude | 2014-07-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROBERTO DONADELLO, MANAGING DIR., |
| Manufacturer Street | VIA DELLE NAZIONI 9 |
| Manufacturer City | BUSSOLENGO, VERONA 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal | 37012 |
| Manufacturer Phone | 9045671900 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WIRE TENSIONER |
| Generic Name | WIRE TENSIONER |
| Product Code | JEC |
| Date Received | 2014-06-13 |
| Returned To Mfg | 2014-05-19 |
| Model Number | 18001 |
| Catalog Number | 18001 |
| Lot Number | B183 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX SRL |
| Manufacturer Address | BUSSOLENGO, VERONA IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-13 |