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 12/17/2019

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 the proximal screws broke post op and remains in the patients body.No more information are available.No x-rays are available.Devices are already discarded and not available for investigation.Update 17-aug-2020: during a removal surgery the head of the screws broke off at the proximal end.The distal part of the screws could not be removed and will be left inside of the patient.The plate and the head of the screws were removed from the patient.

• Brand Name: SCREW, CANCELLOUS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 10421470
• MDR Text Key: 203370013
• Report Number: 1220246-2020-02052
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867010567
• UDI-Public: 00888867010567
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K032187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: SCREW, CANCELLOUS
• Device Catalogue Number: AR-13280-50
• Device Lot Number: 10105323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other