MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2006-07-19 for SURETAC RAPID DELIVERY SYSTEM WITHOUT GLENOID GUID 7209818 manufactured by Smith & Nephew, Inc. - Endoscopy Division.
[20509930]
During a shoulder arthroscopy procedure, the handle broke on three separate devices while drilling. Sales representative for smith+ nephew confirmed that the surgeon was performing a labral repair and loaded the guidewire into the drill and started to drill when the handle broke. This happened on two additional devices. A delay of over an hour took place. The repair was completed with a competitor's drill and our suretac. Sales rep. Was not at the case, but has since instructed the surgeon on the correct usage of the suretac rds system. No pt injury or complications took place.
Patient Sequence No: 1, Text Type: D, B5
[20809503]
H10: three rds drills were returned for evaluation. All are broken; one at the arbor and the other two at the handle. The arbor is missing from two of the devices. The arbor that remains attached to a portion of the handle is cracked and deformed. The plungers on two devices are frozen within the handle. Conclusion: improper use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219602-2006-00100 |
| MDR Report Key | 740457 |
| Report Source | 06,07 |
| Date Received | 2006-07-19 |
| Date of Report | 2006-07-19 |
| Date of Event | 2005-06-08 |
| Date Facility Aware | 2006-06-08 |
| Report Date | 2006-07-19 |
| Date Mfgr Received | 2006-06-19 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2006-07-27 |
| 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 | 2006-07-19 |
| Returned To Mfg | 2006-06-23 |
| Model Number | 7209818 |
| Catalog Number | 7209818 |
| Lot Number | 50162300 |
| ID Number | * |
| Device Expiration Date | 2009-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 728327 |
| 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 | 2006-07-19 |