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 2006-08-10 for CLEAR-TRAC COMPLETE 5.5MM X 72MM 7209987 manufactured by Smith & Nephew, Inc., Endoscopy Division.
[17435203]
A piece did break off inside body of pt and they were able to remove most of it. Surgeon introduced the disposable cannula, pushing the cannula into the shoulder joint. When the cannula was in place, he removed the guiding rod from the posterior portal and re-inserted the telescope to carry on with the procedure. It was then discovered that, the tip portion of the disposable was broken. A delay of thirty minutes resulted. Back-up devices were available.
Patient Sequence No: 1, Text Type: D, B5
[17661663]
Evaluation of the device showed the distal end of the cannula is broken and small pieces are missing. Condition of the device is consistent with excessive force being applied however, a conclusion could not be made for the reported failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219602-2006-00115 |
| MDR Report Key | 773688 |
| Report Source | 01,06,07 |
| Date Received | 2006-08-10 |
| Date of Report | 2006-08-10 |
| Date of Event | 2006-03-20 |
| Date Facility Aware | 2006-03-20 |
| Report Date | 2006-08-10 |
| Date Mfgr Received | 2006-07-10 |
| Date Added to Maude | 2006-10-30 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DONNA LATEIGNE |
| 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 | CLEAR-TRAC COMPLETE 5.5MM X 72MM |
| Generic Name | SEARCH OF RECORDS SHOWS |
| Product Code | NBL |
| Date Received | 2006-08-10 |
| Returned To Mfg | 2006-07-27 |
| Model Number | 7209987 |
| Catalog Number | 7209987 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 761466 |
| Manufacturer | SMITH & NEPHEW, INC., ENDOSCOPY DIVISION |
| Manufacturer Address | * ANDOVER MA * US |
| Baseline Brand Name | CLEAR-TRAC COMPLETE 5.5MM X 72MM |
| Baseline Generic Name | SEARCH OF RECORDS SHOWS |
| Baseline Model No | 7209987 |
| Baseline Catalog No | 7209987 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-08-10 |