MAUDE Adverse Event Report: ARTHREX, INC. QCKFIX SCRW,TI CANN ST,CANC.,4.0X 40MM; SCREW, FIXATION, BONE

Model Number	QCKFIX SCRW,TI CANN ST,CANC.,4.0X 40MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The device was reported to have been discarded.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
During social safeguard cyber review (arthrex chatter community), on 9/5/2018, a potential device issue was discovered.Additional information was requested and received on 9/10/2018.Additional information obtained 9/10/2018: during an mrp fusion procedure a 4.0 x 40mm quickfix cannulated titanium screw, ar-8740-40pts (lot unknown), broke at the end of insertion.The only part of the screw that broke was the head of the screw during the last few turns of insertion.The sales rep reported, per the surgeon, that the screw is still compressing the fusion site and doing it's intended purpose.A 3.5/4.0mm hexalobe t15 driver (ar-8943-12) was being used to implant the screw.It was also reported that a new resident physician was inserting the screw under supervision of the attending physician.It was reported to be unknown if the screw broke due to lack of experience by the new resident physician or due to screw malfunction.Prior to implantation the bone was prepped with a 2.5mm cannulated drill bit (ar-8737-09).The head of the screw that broke off was discarded by the facility.

• Brand Name: QCKFIX SCRW,TI CANN ST,CANC.,4.0X 40MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7922141
• Report Number: 1220246-2018-00672
• Device Sequence Number: 1653586
• Product Code: HWC
• UDI-Device Identifier: 00888867046443
• UDI-Public: 00888867046443
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: QCKFIX SCRW,TI CANN ST,CANC.,4.0X 40MM
• Device Catalogue Number: AR-8740-40PTS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other