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

Model Number 25-2810

Device Problems Device Damaged by Another Device (2915); Material Twisted/Bent (2981)

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

Event Date 08/15/2018

Event Type  malfunction  

Event Description

It was reported that while using the 2.8mm drill kit for the q-fix in the shoulder as the assistant was drilling and the surgeon was holding the guide the guide bent and the drill started to shear the metal of the guide.They stopped immediately when they noticed.It was opened a new drill kit and this one worked fine.No significant delay or patient injury reported.

Manufacturer Narrative

The reported disposable kit 2.8mm shoulder q-fix, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual evaluation cannot be performed and customer's complaint cannot be confirmed.From the information provided, it was reported that as the physician drills the guide bent and the drill started to shear the metal of the guide.An exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) excessive force (2) improper alignment of the inserter.

• Brand Name: DISPOSABLE KIT 2.8MM SHOULDER Q-FIX
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• MDR Report Key: 7852064
• MDR Text Key: 119659221
• Report Number: 3006524618-2018-00454
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00817470011050
• UDI-Public: (01)00817470011050(17)201209(10)2008942
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2020
• Device Model Number: 25-2810
• Device Catalogue Number: 25-2810
• Device Lot Number: 2008942
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 09/06/2018
• Supplement Dates Manufacturer Received: 10/22/2018
• Supplement Dates FDA Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1