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 2020-03-12 for XPS? BLADE 1884012HR manufactured by Medtronic Puerto Rico Operations Co..
[183129199]
Analysis found that the middle assembly tip broke off at the spiral wrap and the inner spiral wrap was deformed which would have resulted in the reported event. The broken tip measured 0. 45? With a piece of spiral wrap extending outward. There was uneven wear inside the middle assembly cutting mouth opening. There was grease on the inner assemblies as required by the drawing. There was deformation of the rotating hub consistent with improper loading the blade into the hand piece and excess pressure applied after being properly loaded: dimples on the front hub prior to the locking area caused by a misalignment of the hand piece locking mechanism, locking area deformation caused by the back side of the front collet of the hand piece, and elongation of the locking divots. Although there was hub deformation, the blade loaded properly into the hand piece. Although there was damage to both assemblies, the inner and middle assemblies spun freely by hand using the hubs which indicates there was no interference fit. There was no damage to the cutting teeth. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183129200]
A healthcare provider (hcp) reported that when the new product was opened during set-up, the tip had been broken. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-05228 |
| MDR Report Key | 9824204 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2018-12-13 |
| Date Added to Maude | 2020-03-12 |
| 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 | 2020-03-12 |
| Returned To Mfg | 2020-02-19 |
| Model Number | 1884012HR |
| Catalog Number | 1884012HR |
| Lot Number | HG319PZ |
| 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 | 2020-03-12 |