MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-01-14 for STERNUM BLADE GUARD 4107008000 manufactured by Stryker Instruments-kalamazoo.
[35971300]
It was reported during product inspection at the user facility, the customer observed that several pieces of metal were removed from the tip of thad blade guard. The customer was concerned if the metal pieces remain in a patient and the potential to cause damage. No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[36814853]
Patient Sequence No: 1, Text Type: N, H10
[36814854]
It was reported during product inspection at the user facility, the customer observed that several pieces of metal were removed from the tip of the blade guard. The customer was concerned if the metal pieces remain in a patient and the potential to cause damage. No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[38320173]
The reported event, there is advanced wear on the distal tip of the blade guard, was not confirmed. However, the reported event of metal pieces came off of the device, was confirmed. The technician observed damage to the tip of the device and a small amount of material was missing. Further visual inspection revealed that the leg was bent and damaged. Based on a review of risk documentation and age of the device, improper use including using excessive lateral force during operation can cause or contribute to the reported event.
Patient Sequence No: 1, Text Type: N, H10
[38320174]
It was reported during product inspection at the user facility, the customer observed that several pieces of metal were removed from the tip of the blade guard. The customer was concerned if the metal pieces remain in a patient and the potential to cause damage. No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2016-00054 |
| MDR Report Key | 5366310 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-01-14 |
| Date of Report | 2015-12-18 |
| Date of Event | 2015-12-18 |
| Date Mfgr Received | 2016-02-12 |
| Date Added to Maude | 2016-01-14 |
| 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. CASEY METZGER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERNUM BLADE GUARD |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Product Code | KIJ |
| Date Received | 2016-01-14 |
| Returned To Mfg | 2016-01-08 |
| Catalog Number | 4107008000 |
| 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 | 2016-01-14 |