MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2009-06-18 for ORIGINAL STEINHAUSER RAMUS CHISEL, SLIGHTLY CURVED 01-09561 manufactured by Stryker Osteosynthesis Freiburg.
[1259204]
During the surgery, the blade fell down in the surgical site. The surgeon had many difficulties to catch the blade from the pt. On may 25, the sales rep went to the customer and made the surgeon fill in the complaint form. During the surgery, the primary product broke. Then, the surgeon tried to use the other two items but he noticed that in both cases, the catting sides were not uniform but they looked "toothed". Finally the surgeon ended the surgery using another item.
Patient Sequence No: 1, Text Type: D, B5
[8312562]
Na
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010177-2009-00064 |
| MDR Report Key | 1461853 |
| Report Source | 01,05 |
| Date Received | 2009-06-18 |
| Date of Report | 2009-05-22 |
| Date of Event | 2009-05-20 |
| Date Mfgr Received | 2009-05-22 |
| Date Added to Maude | 2010-06-01 |
| 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 | ROB YAMASHITA |
| Manufacturer Street | 750 TRADE CENTRE WAY STE 200 |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693245346 |
| Manufacturer G1 | STRYKER OSTEOSYNTHESIS FREIBURG |
| Manufacturer Street | BOTZINGER STRASSE 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-79111 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORIGINAL STEINHAUSER RAMUS CHISEL, SLIGHTLY CURVED |
| Generic Name | INSTRUMENT |
| Product Code | EML |
| Date Received | 2009-06-18 |
| Model Number | NA |
| Catalog Number | 01-09561 |
| Lot Number | JC400F74SU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER OSTEOSYNTHESIS FREIBURG |
| Manufacturer Address | FREIBURG D-79111 GM D-79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-18 |