MAUDE Adverse Event Report: ARTHREX, INC. CONTURLK HTO PLT,FLAT,LFT,71MM; PLATE, FIXATION, BONE

Model Number	CONTURLK HTO PLT,FLAT,LFT,71MM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/21/2020
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 root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that contourlock screws broke inside of the patient.A plate was removed but on two screws out of five, the distal end broke off and remains inside of the patient.At the moment, only two images have been made available, no further information has been made available.Further questions being asked.Update 22-jul-2020: 3 proximal screws broke at proximately 1 cm away from the screw head, see photo attached.The surgeon could remove 1 screw end.The other 2 screws were difficult to remove because larger holes will weaken the tibia plateau.The broken instrument visible on the image on the table was some kind of a coring reamer/ removal tool but is not an arthrex device.Part- , lot numbers, post op x-rays and date of initial surgery was requested as well from the sales rep to the surgeon.Update 05-aug-2020: information received that the following screws are defect and will be returned: ar-13280-50 / lot:10198579.Ar-13280-55 / lot:10184902.Ar-13280-55 / lot: 10208687.No more information nor x-rays are available from the hospital.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-13730-02 contourlock plate was returned for investigation.Visual inspection identified that all six bushings were displaced to varying degrees.Surface scratches were noted on either surface of the device, as well as along the outer diameter of the plate.Due to the received condition of the device (bushing displacement, surface damage along body of device and outer diameter) dimensional analysis was not performed.Material analysis concluded that the ar-13730-02 met all as-received specifications.The returned ar-13730-02 is concomitant to the screw breakage reported on additional lines within this case.The most likely cause of the aforementioned failure modes remains undetermined.It was noted that the method of bone preparation and the bone quality encountered were not recorded.

• Brand Name: CONTURLK HTO PLT,FLAT,LFT,71MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10417043
• Report Number: 1220246-2020-02047
• Device Sequence Number: 2942645
• Product Code: HRS
• UDI-Device Identifier: 00888867015159
• UDI-Public: 00888867015159
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K032187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: CONTURLK HTO PLT,FLAT,LFT,71MM
• Device Catalogue Number: AR-13730-02
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 09/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other