MAUDE Adverse Event Report: ACUMED LLC ACU-SINCH KIT; WASHER, BOLT NUT PLUS SUTURES

Model Number 46-0001-S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Swelling (2091)

Event Type  Injury  

Event Description

A hook plate (from another manufacturer) and an acumed acusinch clavicle repair system were implanted in the patient on (b)(6) 2020.The patient experienced swelling of the wound and debridement was performed once near the anchor.The hook plate was removed via revision surgery on (b)(6) 2021.The acusinch implant anchor was not removed during this surgery.

• Brand Name: ACU-SINCH KIT
• Type of Device: WASHER, BOLT NUT PLUS SUTURES
• 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: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 11378886
• MDR Text Key: 233516208
• Report Number: 3025141-2021-00014
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K112111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/04/2021

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
• Device Model Number: 46-0001-S
• Device Catalogue Number: 46-0001-S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/25/2021
• 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): Required Intervention