MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-03-18 for 2.8MM Q-FIX ALL SUTURE ANCHOR 25-2800 manufactured by Arthrocare Corp..
[184061956]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[184061957]
It was reported that during right shoulder arthroscopic stabilisation surgery, anchor handle/inserter would not engage with drill guide, the surgeon re-drilled through the same hole; however, the anchor inserter still would not advance. The patient's bone was hard. The surgeon used mallet against advice. The inserted tip was noted bent. The surgeon decided not to use another anchor and ended the procedure, which indicates that a void left was left in the patient. No significant delay or patient injuries were reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006524618-2020-00116 |
| MDR Report Key | 9850191 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-04-11 |
| Date Added to Maude | 2020-03-18 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | HOLLY TOPPING |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123913905 |
| Manufacturer G1 | ARTHROCARE CORP. |
| Manufacturer Street | 7000 W. WILLIAM CANNON |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78735 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2.8MM Q-FIX ALL SUTURE ANCHOR |
| Generic Name | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE |
| Product Code | MBI |
| Date Received | 2020-03-18 |
| Model Number | 25-2800 |
| Catalog Number | 25-2800 |
| Lot Number | 2032116 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORP. |
| Manufacturer Address | 7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |