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 2020-02-02 for QFIX 1.8 MINI SUTURE ANCHOR DISP KIT 72290125 manufactured by Arthrocare Corp..
[178189425]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[178189426]
It was reported that, during an open biceps tenodesis, when trying to clear the bone tunnel for q-fix technique by retracting and progressing drill, the latter was stuck/fused to the drill guide and was unable to be removed from it. Although there was not any fragmentation, the pieces broke inside of the patient. After easily removing all pieces from the patient, a new disposable drill kit was opened and used, in the same bone hole, to complete the procedure. Surgery was not significantly delayed. The patient was not harmed. 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 | 3006524618-2020-00039 |
| MDR Report Key | 9656957 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-02-02 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2019-02-02 |
| Date Added to Maude | 2020-02-02 |
| 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 | QFIX 1.8 MINI SUTURE ANCHOR DISP KIT |
| Generic Name | ACCESSORIES,ARTHROSCOPIC |
| Product Code | NBH |
| Date Received | 2020-02-02 |
| Model Number | 72290125 |
| Catalog Number | 72290125 |
| Lot Number | 2027027 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-02 |