FDA Adverse Event
Injury
Summary report: N
Y-KNOT SUTURE CLIP
MDR report key: 177798
·
Received July 18, 1998
Report
- Report Number
- 1222933-1998-00002
- Event Type
- Injury
- Date Received
- July 18, 1998
- Date of Event
- June 16, 1998
- Report Date
- July 17, 1998
- Manufacturer
- INNOVASIVE DEVICES, INC.
- Product Code
- FZP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING THE PT'S OFFICE VISIT ON 5/11/1998, THE DOCTOR NOTED THAT THE ARTHROSCOPIC ROTATOR CUFF REPAIR HE HAD PERFORMED ON 2/3/1998 HAD NOT HEALED. HE PERFORMED A RE-OPERATION (MINI-OPEN ROTATOR CUFF REPAIR) ON 6/16/1998 & REPORTED THAT THE SUTURE BROKE ON TWO Y-KNOT SUTURE CLIPS, PREVENTING THE REPAIR FROM HEALING. THE DOCTOR REMOVED THE Y-KNOTS, & REPLACED THEM WITH REGULAR SUTURE KNOTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | Y-KNOT SUTURE CLIP Implant | SOFT TISSUE APPROXIMATION AND/OR LIGATION | FZP | INNOVASIVE DEVICES, INC. | NA | 11320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Required Intervention |