MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-04-17 for REDUCTION UNIT 80047 manufactured by Orthofix Srl.
[18731969]
The info provided by the local distributor indicates: hospital name: (b)(6); surgeon name: dr (b)(6); date of surgery: (b)(6) 2014; body part to which device was applied: tibia/ankle; surgery description: non union; problem occurred into treatment. Event description: reduction unit 80. 047 had to be replaced 10 weeks after surgery due to movement after fixation (metal fatigue? ) the complaint report form indicates: the device failure caused adverse effects to pt (loss of distraction/correction achieved). The surgery was completed with the used device. The event did not lead to a clinically relevant delay. The device was replaced after 10 weeks in outpatient clinic (no revision surgery). Copies of the operative reports and copies of the x-rays are not available. On (b)(6) 2014, orthofix srl received the following info: date of surgery: (b)(6) 2014. Remark of failure: (b)(6) 2014 (by e-mail). Device replacement: (b)(6) 2014. I honestly don't know, when the reduction unit broke down; may be it was already broken at time of surgery... (it was certainly not a new one; hospital has system on the shelf and -of course- re-use all the re-usable the system components). Pt info: male, about(b)(6) years of age, normal posture (around (b)(6), with ring fixator). Pt current health condition: pt's health is good, i. E. Normal. Vital, good sense of humor. Pt surgery was due to arthrodesis of the ankle as a result of an infectious nonunion of the distal tibial fracture after a motorbike accident. No co-morbidity. Availability of the pre-operative xrays. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18865978]
Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code 80047 (component 800073 lot b19) before the market release. No anomalies have been found. The original lot, manufactured in 2007, was comprised of (b)(4) devices. All of them have already been distributed to the market. According to orthofix srl historical records, this is the first notification received from this specific device lot. Technical evaluation: the returned device, received on (b)(4) 2014 was examined by orthofix srl quality engineering department. The device was subjected to a visual check which evidenced that it is slightly worn. The reduction unit was then disassembled in its components and subjected to dimensional and functional check. The dimensional check, performed on all components, evidenced that the two bushes are slightly under dimension. This is most likely due to the fact they are used and worn. Bushes and cams are single use devices. All other components did not evidence any dimensional anomalies. The functional check evidenced that the micrometric adjustment mechanism is not working properly. The ball joints are still working properly even if the bushes are now slightly under dimension. The results of the technical evaluation evidenced that the device was originally conforming to design specifications. The seizing of the micrometric adjustment mechanism may be due to forcing during previous uses. The medical evaluation summary and the manufacturer comments are provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680825-2014-00011 |
| MDR Report Key | 3779191 |
| Report Source | 01,08 |
| Date Received | 2014-04-17 |
| Date of Report | 2014-04-16 |
| Date of Event | 2014-03-21 |
| Date Mfgr Received | 2014-03-26 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2014-05-01 |
| 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, MANG DIR VP |
| 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 | REDUCTION UNIT |
| Generic Name | REDUCTION UNIT |
| Product Code | JEC |
| Date Received | 2014-04-17 |
| Returned To Mfg | 2014-03-31 |
| Model Number | 80047 |
| Catalog Number | 80047 |
| Lot Number | B19 |
| 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 | 2014-04-17 |