MAUDE Adverse Event Report: ARTHROCARE CORPORATION 1.8MM QFIX REUSABLE CURVED DRILLGUIDE 24; BIT, DRILL

Model Number	72290120
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the distal tip of the guide on the acetabulum was loose.The curved fix guide was pull out of the cannula and the distal tip fell off the inserter.The distal tip was retrieved out of the cannula with no issue.
Additional Manufacturer Narrative
The reported q-fix reusable curved drillguide device, intended for use in treatment, was returned for evaluation.A relationship between the device and reported incident was established based on our visual evaluation.From the information provided, ¿the distal tip of the guide on the acetabulum was loose.The curved fix guide was pull out of the cannula and the distal tip fell off the inserter.¿ the visual inspection shows the device with a broken tip.Functional test cannot be performed in the condition returned.Customer¿s complaint was confirmed.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force.Deterioration of the device due to wear or handling.Excessive force and mishandling can result in failure.As with any surgical instrument, careful attention should be made to assure that excessive force is not placed on this instrument.Do not use if the instrument is damaged or if the instrument is not fully functional.Repeated processing of instruments has minimal effect on product lifetime and function.Visible deterioration such as corrosion or damage resulting from wear and tear or handling is cause for retirement of the instrument from further use.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: 1.8MM QFIX REUSABLE CURVED DRILLGUIDE 24
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• MDR Report Key: 7814701
• Report Number: 3006524618-2018-00433
• Device Sequence Number: 1573497
• Product Code: HTW
• UDI-Device Identifier: 00885556657461
• UDI-Public: (01)00885556657461(10)980617
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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 Model Number: 72290120
• Device Catalogue Number: 72290120
• Device Lot Number: 980617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1