MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-28 for DISPOSABLE KIT 2.8MM SHOULDER Q-FIX 25-2810 manufactured by Arthrocare Corp..
[185514608]
It was reported that during surgery the drill guide from the q-fix implant kit was tight, which caused the drill bit to get stuck in the guide. The procedure was completed with the same device without a significant delay; however, an additional bone hole had to be made in order to position the suture. No patient injury was 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 | 3006524618-2020-00133 |
| MDR Report Key | 9894895 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-28 |
| Date of Report | 2020-03-28 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-01-15 |
| Date Added to Maude | 2020-03-28 |
| 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 | DISPOSABLE KIT 2.8MM SHOULDER Q-FIX |
| Generic Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Product Code | LXH |
| Date Received | 2020-03-28 |
| Model Number | 25-2810 |
| Catalog Number | 25-2810 |
| Lot Number | 2026764 |
| 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 | 2020-03-28 |