MAUDE Adverse Event Report: ACUMED, LLC ACU-SINCH KNOTLESS SYS W/INSRTR 3.5 KIT; WASHER, BOLT NUT

Model Number 46-0023-S

Device Problem Break (1069)

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

Event Date 06/22/2022

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation were inconclusive since the device was not returned for evaluation.Based on the information received, the root cause of the reported event could not be determined.

Event Description

It was reported the surgeon intended to place two acu-sinch knotless implants into the patient.Implant #1: reduction loop knot failure occurred during tensioning causing the reduction limbs to separate.The surgeon applied surgical clamps to the limbs for tensioning to desired reduction level.Implant #2: one of the reduction sutures broke during final tensioning between round button and flip button.Surgeon did not apply further tension and cut the remaining reduction suture.Final syndesmosis reduction was satisfactory to the surgeon yielding no adverse effects for the patient.It was reported there was no delay in procedure.This report is related to report number 3025141-2022-00236 for the other device involved in this event.

• Brand Name: ACU-SINCH KNOTLESS SYS W/INSRTR 3.5 KIT
• Type of Device: WASHER, BOLT NUT
• 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 ; 5035209618
• MDR Report Key: 15079587
• MDR Text Key: 303089117
• Report Number: 3025141-2022-00235
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: 46-0023-S
• Device Catalogue Number: 46-0023-S
• Device Lot Number: 556835
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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