MAUDE Adverse Event Report: ARTHROCARE CORP. 1.8MM Q-FIX DISPOSABLE FLEXIBLE DRILL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	72290118
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drill tip broke off during the case and was left in the bone.It could not be retrieved.No patient injury reported or significant time delay.
Additional Manufacturer Narrative
The reported q-fix disposable flexible drill, intended for use in treatment, was returned for evaluation.A relationship between the device and reported incident was established based on our visual observations.From the information provided, it was reported that the drill tip broke off during the case and was left in the bone.Visual evaluation of the returned disposable drill shows the product was received broken approximately 1cm from distal tip.Flutes appear to be reversed, indicative of torsional overload.Based on visual observations, customers complaint was confirmed.An exact root cause cannot be determined with confidence; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) excessive force.Or (2) levering the drill during use.Excessive force applied to the product or leverage during use can result in product failure or damage to the product.

• Brand Name: 1.8MM Q-FIX DISPOSABLE FLEXIBLE DRILL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7245384
• Report Number: 3006524618-2018-00066
• Device Sequence Number: 110921
• Product Code: LXH
• UDI-Device Identifier: 00885556657447
• UDI-Public: (01)00885556657447(17)201207(10)1211884
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2020
• Device Model Number: 72290118
• Device Catalogue Number: 72290118
• Device Lot Number: 1211884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1