MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-10-23 for SURETAC RAPID DELIVERY SYSTEM WITHOUT GLENOID GUID 7209818 manufactured by Smith & Nephew, Inc. Endoscopy Divis.
[304227]
During 'slap' repair procedure, the tip of the guidewire broke off in the pt's bone and was not removed. A delay of 5-10 minutes took place. The procedure was completed with another suretac device. No pt injury or complications were noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-2003-00154 |
| MDR Report Key | 492044 |
| Report Source | 05,06 |
| Date Received | 2003-10-23 |
| Date of Report | 2003-10-23 |
| Date of Event | 2003-09-22 |
| Date Facility Aware | 2003-09-22 |
| Report Date | 2003-10-23 |
| Date Mfgr Received | 2003-09-22 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2003-10-30 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DONNA LANTEIGNE |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787491576 |
| 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 | 2003-10-23 |
| Model Number | 7209818 |
| Catalog Number | 7209818 |
| Lot Number | 599225 |
| ID Number | * |
| Device Expiration Date | 2006-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 480744 |
| Manufacturer | SMITH & NEPHEW, INC. ENDOSCOPY DIVIS |
| Manufacturer Address | 130 FORBES BLVD. MANSFIELD MA 02048 US |
| Baseline Brand Name | SURETAC RAPID DELIVERY SYSTEM WITHOUT GLENOID GUID |
| Baseline Generic Name | SURETAC RAPID DELIVERY S |
| Baseline Model No | 7209818 |
| Baseline Catalog No | 7209818 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-10-23 |