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

Model Number 70-0413

Device Problems Break (1069); Patient-Device Incompatibility (2682)

Patient Problems Wound Dehiscence (1154); Failure of Implant (1924); Unspecified Infection (1930); Subluxation (4525)

Event Type  Injury  

Manufacturer Narrative

Manufacturing and inspection records were reviewed, and no anomalies were found.The part number 70-0413 plate was returned for evaluation.The batch/lot number was confirmed to be 493591.The returned plate was visually inspected under magnification.The plate was not in good condition and had scratch marks, discoloration, missing anodization, and damage from either the initial implant procedure or the removal surgery.The plate was fractured in two pieces that happened post-op according to the reported event.Under close inspection visually under magnification, the surface of the fracture was sheared off and not indicative of fatigue.The surface was rough with a dull color.This potentially indicates that a high energy event or too much stress caused the plate to break.However, no definitive conclusions can be made as to the exact reason for the failure to occur.

Event Description

It was reported the patient had acute persistent dislocation fracture of the elbow (complex) that could not be closed/reduced.After 7 days of the injury, the initial implant surgery was performed.It was reported the reduction was difficult during the procedure since the entire musculoligamentous complex was also affected.A coronoid and olecranon plate and lateral anchor were inserted during the initial implant procedure."patient with torpid evolution in which the post-op nursing care was not satisfactory" was also reported.Dehiscence of the wound was observed at its middle level post-op and was healed with pico system (negative pressure therapy system) until it closed for 4 weeks (event date unknown).After removing the drain, the wound reopened spontaneously with purulent material discharge.Ct of the elbow revealed lateral collection and rupture of the coronoid plate.Elbow subluxation was also appreciated.Follow up determined both the coronoid plate and olecranon plate were explanted.It was stated the patient had a very complex and unstable lesion and "perhaps the coronoid plate was insufficient to maintain the stabilizing fragment, the infection did not help consolidation and the entire system failed, leading to mechanical stress of the plate and its failure.The anterolateral coronoid fragment could not be synthesized and was displaced, perhaps influencing overall failure." follow up also determined the current status of the patient is that the infection is being resolved, but the patient's elbow is "quite rigid (arthropathy." the patient is undergoing the usual check-ups in consultation.Only the coronoid plate was being returned for evaluation.This report is related to report number 3025141-2023-00019 for the olecranon plate involved.

• Brand Name: CORONOID PLATE, STD, LT
• 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 ; 5035209618
• MDR Report Key: 16218986
• MDR Text Key: 307878754
• Report Number: 3025141-2023-00018
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K102998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70-0413
• Device Catalogue Number: 70-0413
• Device Lot Number: 493591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2023
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2020
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 110 KG