MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-11-13 for SYSTEM 6 STERNUM BLADE 10 PACK 6207097101S1 manufactured by Stryker Ireland Ltd..
[3042230]
It was reported that while setting up before a procedure, the blade broke and the blade guard bent. It was also reported that the processing technician incorrectly loaded the blade and guard into the handpiece. It was further reported that there was not pt involvement and no adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[10322637]
The blade subject to this investigation was not returned to the mfr for evaluation. Lot number info has not been provided to permit further investigation. Investigation results indicate that the blade was not loaded into the handpiece correctly which potentially caused the breakage, however, this cannot be confirmed as the blade was not returned. If the blade is received, an evaluation will be performed and a follow-up mdr will be submitted. The root cause is undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2012-00290 |
| MDR Report Key | 2839966 |
| Report Source | 07 |
| Date Received | 2012-11-13 |
| Date of Report | 2012-10-17 |
| Date of Event | 2012-10-17 |
| Date Mfgr Received | 2012-10-17 |
| Date Added to Maude | 2013-02-21 |
| 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 | UNA BARRY |
| Manufacturer Street | CARRIGTWOHILL BUSINESS & TECHNOLOGY PARK |
| Manufacturer City | CARRIGTWOHILL, CORK |
| Manufacturer Country | EI |
| Manufacturer Phone | 214532963 |
| Manufacturer G1 | STRYKER IRELAND LTD. |
| Manufacturer Street | CARRIGTWOHILL BUSINESS & TECHNOLOGY PARK |
| Manufacturer City | CARRIGTWOHILL, CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM 6 STERNUM BLADE 10 PACK |
| Product Code | DWH |
| Date Received | 2012-11-13 |
| Catalog Number | 6207097101S1 |
| Lot Number | UNK |
| 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 IRELAND LTD. |
| Manufacturer Address | CARRIGTWOHILL, CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-13 |