MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW FT,3.5X 10MM; SCREW, FIXATION, BONE

Model Number SUTR ANCH,CRKSCRW FT,3.5X 10MM

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/03/2020

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 during a brostrom surgery the anchor broke off at the tip of the inserter but the surgeon was able to retrieve the device.In addition a second anchor broke off and remained inside the patient.The surgery was finished successfully despite the remaining anchor inside the patient with a new device with the same part number.Update 10-jun-2020: further information was provided that both anchors are available for evaluation.The surgery was finished successfully with the second implanted anchor.The anchor broke off but the surgeon decided that it was stable enough.

Manufacturer Narrative

Complaint confirmed.Visual inspection of both devices showed the distal tip of the driver (c1662-01) to be missing from the driver of each device.Material analysis of the driver of both devices confirmed that the driver is made of stainless steel 440.Most likely cause of this failure mode is improper bone preparation and/or insertion angle.

• Brand Name: SUTR ANCH,CRKSCRW FT,3.5X 10MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10185538
• MDR Text Key: 196154291
• Report Number: 1220246-2020-01923
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867022607
• UDI-Public: 00888867022607
• Combination Product (y/n): N
• PMA/PMN Number: K061863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SUTR ANCH,CRKSCRW FT,3.5X 10MM
• Device Catalogue Number: AR-1915FT
• Device Lot Number: 10639909
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/03/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other