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

Model Number	SCREW, CANCELLOUS
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/12/2020
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 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10422347
• Report Number: 1220246-2020-02058
• Device Sequence Number: 2991288
• Product Code: HRS
• UDI-Device Identifier: 00888867010567
• UDI-Public: 00888867010567
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K032187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: SCREW, CANCELLOUS
• Device Catalogue Number: AR-13280-50
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 08/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other