MAUDE Adverse Event Report: ACUMEDLLC ACU-SINCH® KIT; BONE PLATE AND SUTURE

Model Number 46-0001-S

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

An acusinch product was implanted in the clavicle of the patient.At some point pos op, the suture anchor pulled out of the bone, likely due to patient noncompliance.A revision surgery occurred.

• Brand Name: ACU-SINCH® KIT
• Type of Device: BONE PLATE AND SUTURE
• Manufacturer (Section D): ACUMEDLLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMEDLLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 9336486
• MDR Text Key: 166978451
• Report Number: 3025141-2019-00556
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K112111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/23/2019

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: 10/23/2019
• Initial Date FDA Received: 11/18/2019
• 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