MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-29 for XPS? BLADE 1884002HRE manufactured by Medtronic Puerto Rico Operations Co..
[177038574]
Visually, the distal tip had broken off the inner cutter which would have resulted in the reported event. The portion that became detached measured approximately 0. 23? In length. The break occurred at the first proximal tooth valley and continued to the 3rd proximal valley. The proximal end of the expanded tip outside diameter was rough and worn which may indicate aggressive use. The outer and inner assembly were deformed in such a way that indicates an impact occurred at the 1st and 3rd proximal valley while moving in oscillate mode which resulted in the observed break. There was no evidence of concentricity issues or bend in the outer tube. When viewed under magnification, there was damage to the hubs that is consistent with improper or difficulty loading the device into the handpiece: dimples on the front hub prior to the locking area caused by a misalignment of the handpiece locking mechanism; locking area deformation caused by the back side of the front collet of the handpiece; and deformation of the proximal inner hub chevrons caused by the handpiece drive mechanism. There was deformation of the hub locking area consistent with aggressive use. The information most likely indicates erratic torsional loads due to aggressive use and improper loading caused the break. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[177038575]
A health care provider (hcp) reported that a blade tip was damaged. There was no patient impact. The procedure was completed with backup product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-02070 |
| MDR Report Key | 9641351 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2017-02-24 |
| Date Added to Maude | 2020-01-29 |
| 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 PUERTO RICO OPERATIONS CO. |
| Manufacturer Street | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK |
| Manufacturer City | JUNCOS PR 00777 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 |
| 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 | 2020-01-29 |
| Returned To Mfg | 2020-01-17 |
| Model Number | 1884002HRE |
| Catalog Number | 1884002HRE |
| Lot Number | HG1PEDA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-29 |