MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2003-09-12 for SURETAC RAPID DELIVERY SYSTEM WITHOUT GLENOID GUID 7209818 manufactured by Smith & Nephew Inc. Endoscopy Divis.
[303749]
It was reported that the surgeon noticed after the guidewire was removed, the tac was "smacked" down. It is believed at this time that the adapter came loose as the guidewire was no longer keeping alignment. Prior to closing the pt, the surgeon took one last look inside and saw the adapter free in the shoulder. Attempting retrieval of the piece was delayed by 20 minutes as the surgeon had a syncopal episode. After the delay, he used graspers to remove the adapter but the piece came free and fell back into the pt. The piece had moved around the side of the cannula, was located and removed. It was reported that a total delay of approx two hours was experienced. No injuries resulted from this case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-2003-00127 |
| MDR Report Key | 485347 |
| Report Source | 05,06,07 |
| Date Received | 2003-09-12 |
| Date of Report | 2003-09-12 |
| Date of Event | 2003-08-15 |
| Date Facility Aware | 2003-08-15 |
| Report Date | 2003-09-12 |
| Date Mfgr Received | 2003-08-15 |
| Device Manufacturer Date | 2003-01-01 |
| Date Added to Maude | 2003-09-30 |
| 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 | 2003-09-12 |
| Model Number | 7209818 |
| Catalog Number | 7209818 |
| Lot Number | 571722 |
| ID Number | * |
| Device Expiration Date | 2004-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 474233 |
| Manufacturer | SMITH & NEPHEW INC. ENDOSCOPY DIVIS |
| Manufacturer Address | 160 DASCOMB ROAD ANDOVER MA 01810 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 | 2003-09-12 |