MAUDE Adverse Event Report: ARTHREX, INC. SCREW, CANCELLOUS; PLATE, FIXATION, BONE

Model Number SCREW, CANCELLOUS

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/21/2020

Event Type  Injury  

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 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.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.

Manufacturer Narrative

Complaint confirmed.A quantity of four broken cancellous screws were received for investigation.Three out of the four returned screws were broken three to four threads from the head.The fourth screw was found to be missing both the head and the distal-most threads.As such, the four returned screws were not able to be identified by specific part numbers, as the critical dimension to distinguish (screw length) was not maintained post-operatively.Material analysis concluded that each of the four returned screws met all as-received specifications.The most likely cause remains undetermined, although it was noted that the method of bone preparation and the bone quality encountered were not recorded.

• Brand Name: SCREW, CANCELLOUS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10416857
• MDR Text Key: 203360549
• Report Number: 1220246-2020-02045
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867010574
• UDI-Public: 00888867010574
• Combination Product (y/n): N
• PMA/PMN Number: K032187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: SCREW, CANCELLOUS
• Device Catalogue Number: AR-13280-55
• Device Lot Number: 10184902
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/05/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other