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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Non-union Bone Fracture (2369)

Event Date 09/12/2022

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported on (b)(6) 2022 by a sales representative via email that several patients bones would not fuse after surgery using the 7.0 screws.According to facility: "starting in may two of our largest 5.0/7.0 users started seeing patients back in after triple fusions going to nonunion.At first they didn¿t think anything of it but since we have had around 6 cases where 7.0 screws were used (primarily only the subtalar joint) and the patient didn¿t fuse.We revised with 6.7 screws and autograft and patients have done great.Speaking with the physician it almost looks like the 7.0 screws lost compression even after checking final x-rays to confirm the joint was reduced.It didn¿t seem like the screws had backed out but we were unsure if them even coming out a fraction of a mm would have caused the joint to decompress.Recently we have had a few medial calcaneal osteotomies where the 7.0 screws don¿t initially compress and have to be taken out and reinserted.We have drilled and countersunk the screw and still have issues with initial compression.".

• Brand Name: UNK
• 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: 15587277
• MDR Text Key: 301566499
• Report Number: 1220246-2022-05607
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/12/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/12/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other