MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-06-20 for SURETAC RAPID DELIVERY SYSTEM WITHOUT GLENOID GUID 7209818 manufactured by Smith & Nephew Inc., Endoscopy Div..
[864299]
During the procedure of suretac implantation, guidewire would not slide out of the bone with surgeon's normal pull out procedure. Drill was attached to guidewire and run in reverse. Guidewire broke at tip of drill. Incision was made and vise clamp attached to guidewire to remove the remainder of the guidewire. It is believed that the use of a drill to remove the guidewire is ill advised, and we never advise the removal of a bare guidewire with a power drill.
Patient Sequence No: 1, Text Type: D, B5
[8076098]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219602-2008-00146 |
| MDR Report Key | 1063979 |
| Report Source | 07 |
| Date Received | 2008-06-20 |
| Date of Report | 2008-05-23 |
| Report Date | 2008-06-17 |
| Date Mfgr Received | 2008-05-23 |
| Device Manufacturer Date | 2008-01-25 |
| Date Added to Maude | 2009-10-19 |
| 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 | JASON BILOBRAM |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787491630 |
| Manufacturer G1 | SMITH & NEPHEW INC. |
| Manufacturer Street | 130 FORBES BLVD. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURETAC RAPID DELIVERY SYSTEM WITHOUT GLENOID GUID |
| Generic Name | SURETAC RAPID DELIVERY S |
| Product Code | MOU |
| Date Received | 2008-06-20 |
| Returned To Mfg | 2008-06-13 |
| Model Number | 7209818 |
| Catalog Number | 7209818 |
| Lot Number | 50242030 |
| Device Expiration Date | 2010-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW INC., ENDOSCOPY DIV. |
| Manufacturer Address | MANSFIELD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-20 |