MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2007-10-16 for BIO MINI-REVO SUTURE ANCHOR, PRELOADED C6170H manufactured by Conmed Linvatec.
[734859]
It was reported that during the insertion of this suture anchor in a patient's bone, it broke off near the eyelet. A portion of the suture anchor was not retrieved from the bone. The procedure was completed with another suture anchor. There was no injury and only a slight delay related to this event.
Patient Sequence No: 1, Text Type: D, B5
[7864190]
Investigation findings: at this time, this device has not been returned for evaluation. A follow-up report will be submitted if additional information become available. The information for use (ifu) informs the user that 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 the bio mini-revo drill guide, cat. No. C6171 or c6172. The anchor inserter is used for prying. The bio mini-revo implant is advanced too deep. A small amount of forward pressure is not applied while rotating the handle.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2007-00712 |
| MDR Report Key | 929353 |
| Report Source | 06,07 |
| Date Received | 2007-10-16 |
| Date of Report | 2007-09-19 |
| Date Mfgr Received | 2007-09-19 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2007-12-11 |
| 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 | 2007-10-16 |
| Model Number | NA |
| Catalog Number | C6170H |
| Lot Number | BBD16858 |
| ID Number | NA |
| Device Expiration Date | 2008-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 930729 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-16 |