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 2008-05-16 for KINSA SUTURE ANCHOR SYSTEM 72200239 manufactured by Smith & Nephew Inc. Endoscopy Div.
[840241]
It was reported that three anchors were used. Sutures broke and 2 anchors remain in the pt, the third anchor was able to secure the anchor. The procedure experienced a 30 minutes delay and a back-up device was available to complete the repair. There was no pt injury reported and no additional info available at this time.
Patient Sequence No: 1, Text Type: D, B5
[7999654]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219602-2008-00129 |
| MDR Report Key | 1046732 |
| Report Source | 01,06,07 |
| Date Received | 2008-05-16 |
| Date of Report | 2007-12-18 |
| Report Date | 2008-05-08 |
| Date Mfgr Received | 2007-12-18 |
| Device Manufacturer Date | 2007-05-31 |
| Date Added to Maude | 2008-08-07 |
| 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 | 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. |
| 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 | KINSA SUTURE ANCHOR SYSTEM |
| Generic Name | KINSA |
| Product Code | KGS |
| Date Received | 2008-05-16 |
| Model Number | 72200239 |
| Catalog Number | 72200239 |
| Lot Number | 50217113 |
| Device Expiration Date | 2010-05-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1043503 |
| Manufacturer | SMITH & NEPHEW INC. ENDOSCOPY DIV |
| Manufacturer Address | MANSFIELD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-16 |