MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-01-23 for ULTRAFIX RC STITCHPAK, DOUBLE SUTURE, 2.9MM 10282 manufactured by Conmed Linvatec.
[790719]
The customer reported that during insertion of this suture anchor in a quadricep repair, it broke before it could be seated in the patella. The user reported drilling a pilot hole prior to insertion. There was no report of serious injury or surgical delay with this event.
Patient Sequence No: 1, Text Type: D, B5
[8087829]
Investigation findings: conmed linvatec was unable to confirm the reported problem because the suture anchor was discarded by the user facility. The instructions for use (ifu) for this product indicate that the device is intended for use in rotator cuff repairs and contraindicates surgical procedures other than those listed in the indications for use. The customer will be provided add'l info on the use of this device. The user reported using a total of seven anchors in this procedure, four of which were successfully implanted. The other report numbers associated with this event are: 1017294-2008-00030, 1017294-2008-00084.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2008-00029 |
| MDR Report Key | 986084 |
| Report Source | 05,06,07 |
| Date Received | 2008-01-23 |
| Date of Report | 2007-12-26 |
| Date of Event | 2007-12-26 |
| Date Mfgr Received | 2007-12-26 |
| Device Manufacturer Date | 2007-04-01 |
| Date Added to Maude | 2008-09-05 |
| 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 | 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 | ULTRAFIX RC STITCHPAK, DOUBLE SUTURE, 2.9MM |
| Generic Name | SUTURE ANCHOR |
| Product Code | KGS |
| Date Received | 2008-01-23 |
| Model Number | NA |
| Catalog Number | 10282 |
| Lot Number | 00011007 |
| ID Number | NA |
| Device Expiration Date | 2012-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 988143 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-23 |