MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for XPS? BLADE 1882905HRE manufactured by Medtronic Xomed Inc..
[185722452]
The product analysis result indicates that the distal tip had broken off the inner cutter which would have resulted in the reported event. The portion that became detached was not returned but would have measured approximately 0. 17? In length. The break occurred at the first proximal tooth valley. The outer assembly cutting tip was deformed in such a way that indicates the inner blade teeth impacted the outer teeth while moving in a cw direction which resulted in the observed break. All teeth on one side were impacted, decreasing in severity toward the distal end. The teeth on the other side showed some wear. There was a light coating of grease on the inner assembly as required. The expanded tip was rough and worn on the proximal side, it did not appear to be machined. The adjacent inside diameter of the outer tube was rough and worn which may indicate excessive friction due to the deformation of the teeth. There was no evidence of concentricity issues or bends in the outer tube or inner cutter. There were no signs of improperly loading the blade in the handpiece or excess pressure being applied during use. There was no allegation of a defect prior to use. Excess speed or direction cannot be ruled out as a potential cause however the information more likely indicates the blade came in contact with an inappropriate material during cutting. In the returned condition, there was an out of specification condition that is likely related to the complaint (due to physical damage). The most likely underlying cause is consistent with, misuse / use error. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185722453]
A healthcare provider (hcp) reported that the blade broke intra operatively. Customer used back-up product to complete the procedure with no issues. No patient injury and no delay in procedure. Nothing broke off in patient or was left inside patient. Additional information received from rep stating that the blade did not have fragments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2020-00193 |
| MDR Report Key | 9902079 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-09-13 |
| Date Added to Maude | 2020-03-31 |
| 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 | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPS? BLADE |
| Generic Name | BUR, EAR, NOSE AND THROAT |
| Product Code | EQJ |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-17 |
| Model Number | 1882905HRE |
| Catalog Number | 1882905HRE |
| Lot Number | 0218283719 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |