MAUDE Adverse Event Report: ARTHROCARE CORP. 1.8MM QFIX RESUABLE CURVED DRILLGUIDE 12; TROUSERS, ANTI-SHOCK

Model Number	72290119
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: 1.8MM QFIX RESUABLE CURVED DRILLGUIDE 12
• Common Device Name: TROUSERS, ANTI-SHOCK
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7304657
• Report Number: 3006524618-2018-00098
• Device Sequence Number: 11075136
• Product Code: LHX
• UDI-Device Identifier: 00885556657454
• UDI-Public: (01)00885556657454(10)980445
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 72290119
• Device Catalogue Number: 72290119
• Device Lot Number: 980445
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other