MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-11-02 for FEN OPEN CANNULA STRL 279726500 manufactured by Medos International Sàrl Ch.
[125987911]
(b)(4). A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[125987912]
Per reporter, mr (b)(6) decided intraoperatively that he wanted to augment a viper prime 7x50 screw (186770250). The alignment guide (286750150) for the open cement cannula (2797-26-500) wasn? T on the shelf. I explained the required alignment device for the viper prime screw wasn? T available. If he wanted to augment the screw that he would need to do this using the cannula without the alignment guide, however that this isn? T the recommended/on label technique. Additionally that he would need to be very careful the head of the screw shank was aligned with the head of the screw so as not to bend the cannula. Mr (b)(6) proceeded with the technique and on insertion of the cement cannula it snapped off inside the screw. Mr (b)(6) attempted to retrieve the cement cannula but it had snapped off inside the cannula of the screw shank meaning this wasn? T possible. As a result of this mr (b)(6) didn? T cement the screw. He decided to proceed in spite of this, suggesting the purchase of the screw was adequate and inserted the rods, nuts, performed compression and final tightening. Mr (b)(6) advised he didn? T wish to remove the screw to obtain the cannula fragment from the inside of the screw as he had already repositioned his trajectory (increased screw diameter when he did this as a rescue screw 6x50, 7x50) and was concerned regarding the hold.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2018-51042 |
| MDR Report Key | 8034089 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-11-02 |
| Date of Report | 2018-10-23 |
| Date of Event | 2018-10-23 |
| Date Mfgr Received | 2018-10-23 |
| Date Added to Maude | 2018-11-02 |
| 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 | JASON BUSCH |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| Manufacturer G1 | MEDOS INTERNATIONAL SARL |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEN OPEN CANNULA STRL |
| Generic Name | DISPENSER, CEMENT |
| Product Code | KIH |
| Date Received | 2018-11-02 |
| Model Number | 279726500 |
| Catalog Number | 279726500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SàRL CH |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-02 |