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 2020-03-17 for XPS? BLADE 1883519HR manufactured by Medtronic Puerto Rico Operations Co..
[183739457]
Product analysis found out that the reported event? Broken and faulty out of the packet? Insinuates that the device was defective before use in the package however the biological contaminants inside the device and outside indicate use. The middle assembly would index freely however the inner assembly with resistance which is typical of spiral wrap damage from excess speed or improper direction. The inner hub was 0. 07? From its typical position in relation to the rotating hub which is consistent with a stretched spiral wrap. There was some wear to the cutting teeth however it is not likely a causal effect of the reported event. The blade loaded into a handpiece however due to the resistance of the inner assembly, and pressure from the stretched spiral wrap, it would not function. A review of the global complaint data showed no other similar complaints for this lot number. There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause. The information most likely indicates irregular torsional loads from improper speed or direction resulted in the observed damage and lack of function. The labeled maximum recommended speed for this device is 3,000 rpm in oscillate mode / direction. The user? S guide warns? Powered blades should be operated in the oscillate mode only. Operating in the forward mode may cause damage to the blade.? If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183739458]
A health care provider (hcp) reported that a device was broken and faulty out of the packet during the procedure. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-05514 |
| MDR Report Key | 9841244 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-03-18 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-03-17 |
| Returned To Mfg | 2020-03-09 |
| Model Number | 1883519HR |
| Catalog Number | 1883519HR |
| Lot Number | HG3941C |
| 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 | 2020-03-17 |