MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06,07 report with the FDA on 2007-08-31 for MICROMITE STITCHPAK SUTURE ANCHOR 10301 manufactured by Conmed Linvatec.
[703029]
It was reported that during hand surgery this anchor did not deploy, which resulted in use of an alternate brand of product to complete the procedure. There was no reported injury and a minimal delay to secure the alternate device during this event.
Patient Sequence No: 1, Text Type: D, B5
[7859952]
No medwatch form received from the user facility. All sections on this form completed by the manufacturer. Investigation findings: an evaluation confirmed the reported problem. A visual examination found this device is bent and is unable to fit into the inserter because of the bend on the cartridge assembly. This is the first report of this failure for this device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2007-00663 |
| MDR Report Key | 906177 |
| Report Source | 00,05,06,07 |
| Date Received | 2007-08-31 |
| Date of Report | 2007-08-06 |
| Date of Event | 2007-08-02 |
| Date Mfgr Received | 2007-08-06 |
| Device Manufacturer Date | 2007-02-01 |
| Date Added to Maude | 2007-10-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BEVERLY SCHANER |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995169 |
| Manufacturer G1 | CONMED LINVATEC |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROMITE STITCHPAK SUTURE ANCHOR |
| Generic Name | MICROMITE STITCHPAK |
| Product Code | NOV |
| Date Received | 2007-08-31 |
| Returned To Mfg | 2007-08-17 |
| Model Number | NA |
| Catalog Number | 10301 |
| Lot Number | 00003207 |
| ID Number | NA |
| Device Expiration Date | 2012-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 887543 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-31 |