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

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Manufacturing and inspection records could not be reviewed as device model number and batch/lot number is unknown.The device was not returned for evaluation.Based on the information received, the root cause could not be determined.Related reports: 3025141-2024-00052, 3025141-2024-00053, 3025141-2024-00054, 3025141-2024-00055, 3025141-2024-00056, 3025141-2024-00057, and 3025141-2024-00058.

Event Description

Report 4 of 7 in the article " prospective clinical and computed tomography evaluation of calcaneus fractures treated through sinus tarsi approach" by mastracci, j.C., et al, the authors state the traditional lateral extensile approach to the calcaneus allows for excellent visualization but is associated with high wound complication rates.The sinus tarsi approach has been shown to produce similar radiographic outcomes with much lower rates of wound complications.The purpose of the author's study was to prospectively determine clinical and radiographic outcomes in calcaneus fractures treated with a sinus tarsi approach.Twenty-nine patients with 30 calcaneus fractures underwent operative fixation through a sinus tarsi approach and were prospectively evaluated.Routine pre- and postoperative radiographs were obtained, in addition to computed tomography (ct) scans at 6weeks and 12months after surgery.Patient-reported outcomes including american orthopaedic foot & ankle society (aofas) score, visual analog scale (vas) pain score, veterans rand 12-item health survey (vr-12), and foot functional index (ffi) were recorded.Patients were followed for a minimum of 1year postoperation.Patients underwent operative fixation with a low profile anatomically designed plating system (acumed llc) through a sinus tarsi approach.All surgeries were performed by 1 of 7 fellowship-trained orthopaedic surgeons.Patients were included if they sustained a closed sanders type ii or iii calcaneus fracture.The author's patient population was majority male with average age of 53years and average body mass index (bmi) of 27.Fifteen fractures were sanders type ii and 7 were sanders iii classification.One patient was a worker's compensation case.Seven of 22 patients were smokers (tobacco), one patient had idiopathic neuropathy of their bilateral lower extremities.Time from injury to surgery ranged from 1day to 23days, with an average time to surgery of 11days.No patients underwent temporizing procedures prior to definitive fixation such as percutaneous pinning or external fixator.There were no major wound complications (defined as requiring reoperation).The following complications were reported: -four patients had minor wound complications: 1 superficial wound necrosis, 2 superficial wound dehiscence, and 1 superficial surgical site infection.-two patients underwent reoperation for removal of symptomatic hardware.-one patient underwent subtalar fusion at 1 year postoperation.

• 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: 18608316
• MDR Text Key: 334111746
• Report Number: 3025141-2024-00055
• 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,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/30/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/30/2024
• 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