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

Model Number SCREW, CANCELLOUS

Device Problems Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/12/2020

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 after an initial hto surgery on (b)(6) 2019, it was found that the proximal screws broke post op and remains in the patients body.The screws could not be removed during the revision surgery.It's unclear if the screws broke in situ or during the revision surgery.No more information are available.No x-rays are available.Devices are already discarded and not available for investigation.Further questions will be asked.Update 12-aug-2020, asa: it was reported by the customer that some proximal screws were broken.When removing the plate and screws they all broke around 1cm from screwhead.The plate and screws were (partially) taken out.The surgeon decided that he did not want to place another plate due to partial consolidation.

• 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: 10422347
• MDR Text Key: 203460388
• Report Number: 1220246-2020-02058
• 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

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SCREW, CANCELLOUS
• Device Catalogue Number: AR-13280-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other