MAUDE Adverse Event Report: ARTHROCARE CORP. 1.8MM Q-FIX DISPOSABLE FLEXIBLE DRILL; BIT, DRILL

Model Number	72290118
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a shoulder arthroscopy, one 1.8 mm q-fix drill broke off into the glenoid.It is unknown whether the fragments were removed from the patient.It is also unknown how the surgery was completed and if it was delayed.The patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device reported, used in treatment, was not returned for evaluation.The relationship between the product and reported incident cannot be established.Without the reported product a visual inspection and functional evaluation cannot be performed and customer´s complaint cannot be confirmed.Potential factors unrelated to the design or manufacture of the device that may lead to the failure reported include, but are not limited to: (1) excessive force.(2) tissue thickness.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: 1.8MM Q-FIX DISPOSABLE FLEXIBLE DRILL
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9826328
• Report Number: 3006524618-2020-00105
• Device Sequence Number: 2814477
• Product Code: HTW
• UDI-Device Identifier: 00885556657447
• UDI-Public: 00885556657447
• Combination Product (Y/N): N
• 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): 04/21/2020

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 Model Number: 72290118
• Device Catalogue Number: 72290118
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1