MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2006-12-22 for MICROMITE STITCHPAK SUTURE ANCHOR 10301 manufactured by Conmed Linvatec.
[16722977]
It was reported that the barbs on the anchor were not present which resulted in the device not holding when deployed. An alternate technique was used to complete the procedure. There was no reported injury nor delay related to this event.
Patient Sequence No: 1, Text Type: D, B5
[16907445]
Investigation findings: the device was received for evaluation with the barbs attached so the reported problem could not be confirmed. A visual examination found the barbs/ring fingers to be bent. This type of damage can occur from lateral force or from misalignment of the inserter gun.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2006-00620 |
| MDR Report Key | 800155 |
| Report Source | 01,07,08 |
| Date Received | 2006-12-22 |
| Date of Report | 2006-11-27 |
| Date Mfgr Received | 2006-11-27 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2007-01-05 |
| 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 | 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 | 2006-12-22 |
| Returned To Mfg | 2006-12-11 |
| Model Number | NA |
| Catalog Number | 10301 |
| Lot Number | 00015106 |
| ID Number | NA |
| Device Expiration Date | 2011-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 787695 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | * LARGO FL * US |
| Baseline Brand Name | MICROMITE STITCHPAK SUTURE ANCHOR |
| Baseline Generic Name | MICROMITE STITCHPAK |
| Baseline Model No | NA |
| Baseline Catalog No | 10301 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-22 |