MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-06-19 for SYSTEM 6 STERNUM BLD-30.5X1MM 6207097101 manufactured by Stryker Instruments-kalamazoo.
[5846417]
It was reported that prior to use in a surgical procedure, it was noted that the blade seemed to be 1/16 inch longer than previous blades. It was also reported that it was difficult to lock the blade into place. It was further reported that there were no delays and no adverse consequences as a result of this event. It was further reported that the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[13471649]
Follow up report will be filed once the quality investigation is complete. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[29301217]
The concomitant device ((b)(4)) in addition to 2 blades from the same lot, were returned for evaluation. The 2 returned blades met measurement specifications. The blade subject to this event was not returned to the manufacturer for evaluation. Investigation results of the handpiece saw had confirmed that full blade insertion was blocked by debris in the drivetrain, the debris was potentially as a result of improper cleaning techniques. The ifu (instruction for use) recommends cleaning and sterilization procedures.
Patient Sequence No: 1, Text Type: N, H10
[29301218]
It was reported that prior to use in a surgical procedure, it was noted that the blade seemed to be 1/16 inch longer than previous blades. It was also reported that it was difficult to lock the blade into place. It was further reported that there were no delays and no adverse consequences as a result of this event. It was further reported that the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2015-02228 |
| MDR Report Key | 4855734 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-06-19 |
| Date of Report | 2015-05-27 |
| Date of Event | 2015-05-27 |
| Date Mfgr Received | 2015-10-14 |
| Device Manufacturer Date | 2015-03-16 |
| Date Added to Maude | 2015-06-19 |
| 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 | 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 | SYSTEM 6 STERNUM BLD-30.5X1MM |
| Generic Name | BLADE, SAW, SURGICAL, CARDIOVASCULAR |
| Product Code | DWH |
| Date Received | 2015-06-19 |
| Returned To Mfg | 2015-06-17 |
| Catalog Number | 6207097101 |
| Lot Number | 15075026 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-06-19 |