MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-06-18 for STERNUM BLADE 0298097100 manufactured by Stryker Instruments-kalamazoo.
[3553096]
It was reported that during a surgical procedure, 2 blades broke at the mount. It was also reported that there was a minimal delay as a result of this event. It was further reported that there were no adverse consequences and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[10855315]
Manufacturing records were reviewed, no issues were identified which may have contributed to this event. The returned blades were measured where possible and all critical specifications were met. Investigation results indicate the break on the blades were consistent with the blades being bent towards the blade guard while cutting. This impact force combined with a bending force potentially caused the blades to break; however, this cannot be confirmed. The root cause is undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2013-01425 |
| MDR Report Key | 3176013 |
| Report Source | 06 |
| Date Received | 2013-06-18 |
| Date of Report | 2013-05-21 |
| Date of Event | 2013-05-16 |
| Date Mfgr Received | 2013-05-21 |
| Device Manufacturer Date | 2012-09-08 |
| Date Added to Maude | 2013-06-18 |
| 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 | 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 | STERNUM BLADE |
| Generic Name | BLADE, SAW, SURGICAL, CARDIOVASCULAR |
| Product Code | DWH |
| Date Received | 2013-06-18 |
| Returned To Mfg | 2013-06-04 |
| Catalog Number | 0298097100 |
| Lot Number | 12251027 |
| Device Expiration Date | 2017-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2013-06-18 |