MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2004-12-23 for SURETAC RAPID DELIVERY SYSTEM WITHOUT GLENOID GUID 7209818 manufactured by Smith & Nephew, Inc. Endoscopy Div.
[19026389]
No product is being returned for evaluation therefore, no determination could be made for the reported device failure. It appears the guidewire became bent during the surgery, which may have caused it to become stuck in the suretac, but this cannot be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[19053029]
During a routine slap arthroscopic repair, a briefing on how to use the rds system was given prior to surgery. During the procedure, the technique was followed as recommended in the relevant technique guide. While pounding the implant into the glenoid some resistance was experienced. Once the suretac implant was in a satisfactory position, the surgeon attempted to remove the guide wire. Considerable force was used trying to remove the guide wire by pulling the wire while gripping with pliers. A drill with jacobs chuck was attached to the drill to drive the wire under power to remove it. At this point, the guide wire snapped. On x-ray the guide wire can be clearly seen embedded into the glenoid and it is bent in the middle to an angle of approximately 20 deg. The superior broken end of the guide wire appears to be approximately 2-3mm below the surface of the glenoid. The surgeon did not experience a "significant" delay (>40 minutes) to the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-2004-00140 |
| MDR Report Key | 782331 |
| Report Source | 01,06,07 |
| Date Received | 2004-12-23 |
| Date of Report | 2004-12-23 |
| Date of Event | 2004-11-18 |
| Date Facility Aware | 2004-11-18 |
| Report Date | 2004-12-23 |
| Date Mfgr Received | 2004-11-26 |
| Date Added to Maude | 2006-11-21 |
| 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 | DONNA LANTEIGNE |
| Manufacturer Street | 150 MINUTEMAN RD |
| 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 | 2004-12-23 |
| Model Number | 7209818 |
| Catalog Number | 7209818 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 770129 |
| Manufacturer | SMITH & NEPHEW, INC. ENDOSCOPY DIV |
| Manufacturer Address | * ANDOVER MA * 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 | 2004-12-23 |