MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-08-05 for UNKNOWN_INSTRUMENTSTIRE_PRODUCT UNK_ICO manufactured by Stryker Instruments-kalamazoo.
[17163063]
It was reported that the attachment was wobbling when the bur was inserted into the chuck. The devices were sent to another department for testing and it was noticed that the 2 burs used were bent. It was further reported that there was no patient impact and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[17624194]
The device is not available for return. A follow up report will be filed once the quality investigation is complete. Device discarded by customer.
Patient Sequence No: 1, Text Type: N, H10
[18923534]
It was reported that the attachment was wobbling when the bur was inserted into the chuck. The devices were sent to another department for testing and it was noticed that the 2 burs used were bent. It was further reported that there was no patient impact and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[19123126]
The devices involved in this reported event were not returned for evaluation. Therefore the complaint could not be confirmed. A review of the associated handpiece's ifu list possible potential causes for the reported event as application of excessive pressure with the cutting accessory, the use of a damaged attachment, cutting accessory and/or handpiece, the use of the wrong size cutting accessory, or the cutting accessory extends too far from the distal end of the attachment or is not properly centered in the attachment. The quality investigation is complete. Device not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2014-02794 |
| MDR Report Key | 3980776 |
| Report Source | 06 |
| Date Received | 2014-08-05 |
| Date of Report | 2014-07-10 |
| Date of Event | 2014-07-10 |
| Date Mfgr Received | 2014-09-26 |
| Date Added to Maude | 2014-08-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. DERVILLIA MURPHY |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal | NA |
| Manufacturer Phone | 214532900 |
| Manufacturer G1 | STRYKER INSTRUMENTS-IRELAND |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN_INSTRUMENTSTIRE_PRODUCT |
| Generic Name | UNKNOWN |
| Product Code | HTT |
| Date Received | 2014-08-05 |
| Catalog Number | UNK_ICO |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-05 |