MAUDE Adverse Event Report: ACUMED, LLC LKG RADIAL HEAD PLATE 3 H STD CURVATURE; PLATE, FIXATION, BONE

Model Number 70-0097

Device Problem Device-Device Incompatibility (2919)

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

Event Date 11/17/2023

Event Type  malfunction  

Manufacturer Narrative

The part number 70-0097 plate was returned for evaluation.The reported screw was not returned as it remains implanted.Examination of returned plate was performed with magnified photography.There was minor instances of damage or wear to the slot in the plate; this included slight indents/nicks on edges of the slot, as well as minor anodization coating wear.There were many instances of scratches on surfaces adjacent to the slot.The print the reported plate was built to was evaluated and measurements of the returned plate were taken.It was determined the slot measurement met specifications.A *non* load-bearing functionality test was conducted by attempting to pass a known-functional screw through the slot of the returned plate *without* imparting moderate to high forces that could potentially damage the plate (i.E.The screw was dropped into the slot, with no pulling force); while this does not replicate the exact in-field condition, which would have had loading present, it provides useful information on if the plate slot is wide enough to pass a screw through without resistance.The noted functionality test utilized a known-functional screw from the co-n23xx part family as sourced from the engineering lab kits; testing found that the screw did not pass through the plate slot, and the screw instead sat in the slot as-expected with no issue.Evaluators were not able to replicate the field failure (i.E.Not able to replicate pull through).It was not possible to fully evaluate the reported event as not all parts relevant to the incident were returned (i.E.The screw).As the functionality test did not replicate the field failure, it appears the slot is performing as expected.It is unclear how the end customer was able to force screw pullthrough, as it was not replicable in this examination.

Event Description

It was reported during surgery, a 2.3mm non-locking screw (part number co-n2318) went through the oblong hole on the radial head plate (part number 70-0098).The screw was unable to be extracted and was left in the patient after "a long process of burring the screw down to flush with the bone".The surgery was completed using a plate from a different manufacturer.This issue prolonged the surgery by 3 hours, and an additional incision on the opposing side had to be made in order to burr the screw flush to the patient's bone.This report is related to report number 3025141-2023-00719 for the other device involved in this event.

• Brand Name: LKG RADIAL HEAD PLATE 3 H STD CURVATURE
• 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: 18324519
• MDR Text Key: 330482320
• Report Number: 3025141-2023-00718
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102998
• 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: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-0097
• Device Catalogue Number: 70-0097
• Device Lot Number: 493527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/14/2023
• 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