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 2020-03-17 for SPEEDLOCK HIP KNOTLESS FIXATION DEVICE 23-2001 manufactured by Arthrocare Corp..
[183697419]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[183697420]
It was reported that during a hip arthroscopy, the ratchet wheel of the speedlock was not working and caused the surgeon to tension the sutures by hand, when the knob was being turned the whole deployment knob came off inside the patient. The anchor shaft and metal wire were removed with graspers. The procedure was successfully completed without significant delay using a back-up device in an additional bone hole. No patient injury or other complications 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 | 3006524618-2020-00112 |
| MDR Report Key | 9840508 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-05-23 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SPEEDLOCK HIP KNOTLESS FIXATION DEVICE |
| Generic Name | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE |
| Product Code | MBI |
| Date Received | 2020-03-17 |
| Model Number | 23-2001 |
| Catalog Number | 23-2001 |
| Lot Number | 2034919 |
| 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 | 2020-03-17 |