MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06,07 report with the FDA on 2007-10-17 for BIO MINI-REVO SUTURE ANCHOR, PRELOADED C6170H manufactured by Conmed Linvatec.
[18610174]
It was reported that during the insertion of the bio mini-revo anchor, into the pt's shoulder, the implant broke when the surgeon attempted to release it from the disposable driver. The broken anchor was removed from the pt without any serious injury, add'l intervention or delay.
Patient Sequence No: 1, Text Type: D, B5
[18687428]
Investigation findings: an evaluation confirmed breakage of the pre-loaded anchor with the proximal end lodged in the driver. Approximately, 6mm of the threaded portion of broken anchor was not returned. In addition, a visual inspection of the returned portion of anchor found it twisted. The information for use (ifu) provides the following information to the user: proper orientation and alignment of instruments is important during implantation of the bio mini-revo to minimize possible breakage of the anchor. Breakage of the bio mini-revo is possible if: the pilot hole is not drilled to an adequate depth. The tap is not inserted to the proper depth. Improper alignment of anchor to pilot hole. Loose or non-secure anchor on driver. It is not used with a bio mini-revo drill guide. The anchor inserter is used for prying. The bio mini-revo implant is advanced too deep. The customer will be provided this information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2007-00702 |
| MDR Report Key | 930106 |
| Report Source | 00,06,07 |
| Date Received | 2007-10-17 |
| Date of Report | 2007-09-25 |
| Date of Event | 2007-09-25 |
| Date Mfgr Received | 2007-09-25 |
| Date Added to Maude | 2007-12-12 |
| 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 | BIO MINI-REVO SUTURE ANCHOR, PRELOADED |
| Generic Name | SUTURE ANCHOR |
| Product Code | KGS |
| Date Received | 2007-10-17 |
| Returned To Mfg | 2007-09-27 |
| Model Number | NA |
| Catalog Number | C6170H |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 924582 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-17 |