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 2019-12-27 for XPS? BUR 311720115E manufactured by Medtronic Xomed Inc..
[175198039]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[175198040]
A health care provider (hcp) reported that during a mastoidectomy, the distal portion of the curved bur (head of the bur) broke at the beginning of its use, all fragments were collected. There was a procedure delay. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
[184382032]
Analysis found visually, the distal cutting tip broke off which would have resulted in the reported event. The portion that became detached measured 0. 13?. The break location corresponds to the distal end of the outer tube after assembly. The configuration of the break was consistent with shear or bending stresses. The nominal shaft diameter at the break is 0. 020? And should not be subjected to bending or prying. The cutting flutes were rough and worn distal to the center line of the head. The remainder of the inner shaft assembly was pulled out of the outer assembly and bent. The proximal tang which locks into the handpiece (when properly loaded) was rough and worn indicating at some point the bur was improperly engaged with the handpiece drive mechanism. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2019-00704 |
| MDR Report Key | 9523479 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-27 |
| Date of Report | 2020-02-26 |
| Date of Event | 2019-12-02 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2019-07-16 |
| Date Added to Maude | 2019-12-27 |
| 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 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? BUR |
| Generic Name | BUR, EAR, NOSE AND THROAT |
| Product Code | EQJ |
| Date Received | 2019-12-27 |
| Returned To Mfg | 2020-01-15 |
| Model Number | 311720115E |
| Catalog Number | 311720115E |
| Lot Number | 0218101724 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-12-27 |