MAUDE Adverse Event Report: ACUMED, LLC; PLATE, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Type  Injury  

Event Description

Report 4 of 14 unpublished clinical data was obtained as part of clinical evaluation.Per the draft cer tec-0276, in clinical data set 1: between january 2015 to march 2023, 23 patients (23 wrists) underwent a total wrist arthrodesis surgery at a uk hospital.Patients had an average age of 53.8 years ± 13.3 years (range 26-86 years).The mean follow-up time was 5 years (range 0.5-9.2 years).In total, 14 wrists were for the right side and 9 were for the left side.All patients used the acumed total wrist fusion plate system and used acumed instrumentation to place the implanted device.In total, 10 neutral plates (70-0362), 5 left small plates (70-0327), 3 right small plates (70-0328), and 5 right standard plates (70-0326).The majority of patients also underwent a concomitant procedure during their total wrist arthrodesis (n=17/23; 73.9%).One patient was readmitted that day after surgery for pain and swelling.They were treated with evaluation and an analgesia; no further treatments were required.Another patient continued to have symptoms related to osteoarthritis and carpal tunnel syndrome; however, these were not related to the total wrist arthrodesis.A patient with a recurrent wound from a low-grade infection had their plate removed after arthrodesis.This resolved the wound problem.Five plates were removed due to patient discomfort or soft tissue irritation caused by plate prominence.Thus, in total, six plates (26.1%) of plates were removed after arthrodesis.The remaining 17 plates did not have complications.There are 14 related report numbers for this event 3025141-2023-00576 through 3025141-2023-00589.

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not received for evaluation.Manufacturing and inspection records could not be reviewed as device information is unknown.Based on the information received, the root cause could not be determined.

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 17971277
• MDR Text Key: 326125755
• Report Number: 3025141-2023-00579
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other