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

Model Number 72290118

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2020

Event Type  malfunction  

Event 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.

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
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9826328
• MDR Text Key: 186171053
• Report Number: 3006524618-2020-00105
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00885556657447
• UDI-Public: 00885556657447
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 72290118
• Device Catalogue Number: 72290118
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 04/20/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1