MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2008-10-27 for FP PK 5.5 SUTURE ANCHOR W/AWL 72201825 manufactured by Smith & Nephew Inc., Endoscopy Div..
[958490]
The suture had been cut off before the user determined that the suture had not really been tightened between the inner and outer parts of the anchor. It is not determined where and if the inner screw is secure in the pt.
Patient Sequence No: 1, Text Type: D, B5
[8216694]
No product is being returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219602-2008-00234 |
| MDR Report Key | 1218691 |
| Report Source | 06,07 |
| Date Received | 2008-10-27 |
| Date of Report | 2008-09-22 |
| Date of Event | 2008-09-22 |
| Date Facility Aware | 2008-09-22 |
| Report Date | 2008-10-20 |
| Date Mfgr Received | 2008-09-22 |
| Device Manufacturer Date | 2008-06-17 |
| Date Added to Maude | 2009-04-15 |
| 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 | JASON BILOBRAM |
| Manufacturer Street | 150 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787491630 |
| Manufacturer G1 | SMITH & NEPHEW INC., ENDOSCOPY DIV. |
| 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 | FP PK 5.5 SUTURE ANCHOR W/AWL |
| Generic Name | FP ANCHOR |
| Product Code | NOV |
| Date Received | 2008-10-27 |
| Model Number | 72201825 |
| Catalog Number | 72201825 |
| Lot Number | 50257972 |
| Device Expiration Date | 2013-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW INC., ENDOSCOPY DIV. |
| Manufacturer Address | MANSFIELD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-27 |