MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-09-17 for CROSSFT SUTURE ANCHOR W/TWO #2 HI-FI, 5.5MM CFP-5502 manufactured by Conmed Linvatec.
[1132389]
During a rotator cuff repair, the tip of the driver broke off inside the anchor as the anchor was being screwed into the pilot hole. The surgeon was unable to retrieve the broken piece with a grasper because it was wedged inside the anchor. The surgeon chose to use the tap and mallet to secure the broken piece of driver into the implant. Following, the pt was transferred to recovery and was discharged in the usual manner.
Patient Sequence No: 1, Text Type: D, B5
[8476826]
Investigation findings: an investigation could not be performed because the driver was discarded by the user facility. The driver used in this event is made of 17-4ph stainless steel and not meant for implantation. The instructions for use (ifu) cautions the user: *proper orientation and alignment of instruments is important during implantation of the crossft suture anchor to minimize possible breakage of the anchor.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2009-00133 |
| MDR Report Key | 1477904 |
| Report Source | 05,07 |
| Date Received | 2009-09-17 |
| Date of Report | 2009-08-27 |
| Date of Event | 2009-08-27 |
| Date Mfgr Received | 2009-08-27 |
| Device Manufacturer Date | 2009-06-01 |
| Date Added to Maude | 2009-09-25 |
| 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 | CROSSFT SUTURE ANCHOR W/TWO #2 HI-FI, 5.5MM |
| Generic Name | FASTENER, FIXATION, NONDEGRADABLE, SOFT |
| Product Code | KGS |
| Date Received | 2009-09-17 |
| Model Number | NA |
| Catalog Number | CFP-5502 |
| Lot Number | 14065 |
| ID Number | NA |
| Device Expiration Date | 2010-12-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-09-17 |