MAUDE Adverse Event Report: ACUMED, LLC; PIN, FIXATION, SMOOTH

Device Problem Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

It was reported two (2) 1.6mm diameter ring pins from the acumed tension band pin system were used for an avulsion fracture of the calcaneal tuberosity.Based on the tension band pin system instructions for use (ifu), the indications for use are malleolar, patella, and olecranon fracture fixation in tension band wiring procedures.Based on the information presented within the article, the 1.6 mm diameter ring pins were used off-label.Related report: 3025141-2023-00308.

Event Description

In the article " avulsion fracture of the calcaneal tuberosity treated with novel surgical technique using the combination of the side-locking loop suture technique and ring pins: a case report" by shota et al, the authors reported a novel surgical technique using a the combination of the side-locking loop suture technique and ring pins (two 1.6mm diameter ring pins from the acumed tension band pin system) in order to treat an avulsion fracture of the calcaneal tuberosity in one patient.It was reported at 3 months post-op the ct showed complete bone union, and two years after surgery, the patient had no symptoms nor any dysfunctions.This is an off-label use of the tension band pin system.This is report 1 of 2 for the two (2) 1.6mm ring pins used in the surgical technique presented by the authors.

• Type of Device: PIN, FIXATION, SMOOTH
• 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: 16925049
• MDR Text Key: 315172953
• Report Number: 3025141-2023-00307
• Device Sequence Number: 1
• Product Code: HTY
• 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: 05/11/2023

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: 05/01/2023
• Initial Date FDA Received: 05/12/2023
• 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
• Patient Age: 78 YR
• Patient Sex: Female