MAUDE Adverse Event Report: ARTHROCARE CORP. DISPOSABLE KIT 2.8MM SHOULDER Q-FIX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 25-2810

Device Problem Mechanical Jam (2983)

Patient Problem Injury (2348)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

The reported device, intended to be used in treatment, was returned for evaluation.There was a relationship found between the reported incident and the returned device.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was an repeat event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found statement indicating how to properly use the device.Visual inspection of the q-fix disposable kit 2,8mm shoulder, shows a returned drill with deep grooves on the shank with an incorporated chip probably caused by an eroded chip inside the tube.The eroded metal part of the drill was visually inspected under magnification and sent back in a grip bag with the complaint.No manufacturing abnormalities visible.The device is a single use device and could not be functional tested.The drill got stuck when tried to slide the drill down the guide; the drill was stuck inside the guide and was removed for further investigation by using a tool.The complaint was verified and the root cause was determined by inadequate physical force resulting in wear of the appropriate components.Factors that could have contributed to the reported event include: excessive force.

Event Description

It was reported that during a hip surgery, when tried to slide the drill down the guide, it got stuck.The procedure was completed without significant delay using a back-up device in an additional bone hole.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: DISPOSABLE KIT 2.8MM SHOULDER Q-FIX
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10690762
• MDR Text Key: 211689378
• Report Number: 3006524618-2020-00891
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00885556724651
• UDI-Public: 885556724651
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 25-2810
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 10/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention