MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-28 for 1.8MM QFIX RESUABLE CURVED DRILLGUIDE 12 72290119 manufactured by Arthrocare Corp..
[101235223]
Patient Sequence No: 1, Text Type: N, H10
[101235224]
It was reported that q-fix drill guide slot was wider than the diameter of the drill bit, causing that surgeon drilled a hole in his finger. No unit to return.
Patient Sequence No: 1, Text Type: D, B5
[114100761]
Complained device was not returned for evaluation, consequently, a relationship between the product and reported incident cannot be established and complaint cannot be confirmed. From the information provided in the complaint, the q-fix drill guide handle slot was wider than the diameter of the drill bit, causing that surgeon drilled a hole in his finger. An exact root cause cannot be determined with confidence; however, a factor that could have contributed to the reported event includes: misalignment between drill guide and drill while inserting the drill into the drill guide. Incorrect alignment between the 2 instruments can result in user injury. Design changes have been implemented to the drill guide. Changes to the drill guide handle drain slots were implemented to address the reported complaint. The drain slots have been replaced with a drilled hole on both sides to prevent the drill from poking thru the drill slot. The reported drill guide was manufactured prior the implementing the changes. There were no indications that would suggest that the device did not meet product specifications upon release into distribution. It was reported that the surgeon drilled a hole in his finger. The only treatment indicated is direct pressure and dressing to stop the bleeding. There is no report of the current condition of the surgeon's finger, and the device was disposed of during the surgery. It was also indicated that there was no complication with the patient. Therefore, based on the lack of clinical information, a clinical assessment is unable to be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006524618-2018-00098 |
| MDR Report Key | 7304657 |
| Date Received | 2018-02-28 |
| Date of Report | 2018-04-16 |
| Date of Event | 2018-01-29 |
| Date Mfgr Received | 2018-01-29 |
| Device Manufacturer Date | 2017-11-21 |
| Date Added to Maude | 2018-02-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| 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 | 0 |
| Brand Name | 1.8MM QFIX RESUABLE CURVED DRILLGUIDE 12 |
| Generic Name | TROUSERS, ANTI-SHOCK |
| Product Code | LHX |
| Date Received | 2018-02-28 |
| Model Number | 72290119 |
| Catalog Number | 72290119 |
| Lot Number | 980445 |
| 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 | 1. Other | 2018-02-28 |