MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2006-06-23 for SURETAC RAPID DELIVERY SYSTEM W/O GLENOID GUIDE 7209818 manufactured by Smith & Nephew, Inc., Endoscopy Division.
[19248206]
Sales rep reported that once the guide pin was removed after the suretac was placed, it was noticed that the tip of the pin was broken and missing. X-ray confirmed that the tip was in the suretac, in the pt. Surgery was converted to an open-procedure in order to remove both the suretac and the broken tip. Bankart repair was completed using a competitor's device. The issue caused a one hour delay.
Patient Sequence No: 1, Text Type: D, B5
[19327512]
Device is not being returned for evaluation therefore, no determination could be made for the reported device failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219602-2006-00091 |
| MDR Report Key | 731948 |
| Report Source | 06,07 |
| Date Received | 2006-06-23 |
| Date of Report | 2006-06-22 |
| Date of Event | 2006-05-17 |
| Date Facility Aware | 2006-05-17 |
| Report Date | 2006-06-22 |
| Date Mfgr Received | 2006-05-24 |
| Date Added to Maude | 2006-07-07 |
| 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 W/O GLENOID GUIDE |
| Generic Name | SURETAC RAPID DELIVERY |
| Product Code | MOU |
| Date Received | 2006-06-23 |
| Model Number | 7209818 |
| Catalog Number | 7209818 |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | N |
| Device Age | UNK |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 720238 |
| Manufacturer | SMITH & NEPHEW, INC., ENDOSCOPY DIVISION |
| 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 | 2006-06-23 |