MAUDE Adverse Event Report: ACUMED, LLC 2.3 MM X 14 MM HEXALOBE MULTISCREW; SCREW, FIXATION, BONE

Model Number 3004-23014-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Report 6 of 11.It was reported a broken wrist fusion plate broke post-operatively (event date unknown) and was revised.It was also reported the reason was "a dog".The original implants (plates and screws) were explanted.No additional information is available despite follow up attempts.

Manufacturer Narrative

Manufacturing and inspection records could not be reviewed as device model number and batch/lot number is unknown.Although it was reported the device is available for evaluation, the device was not returned for evaluation.Based on the information received, the root cause could not be determined.

Manufacturer Narrative

A plate and ten (10) screws were returned for evaluation.The returned products were visually inspected.To confirm fracture pattern holding the plate with the laser markings in the correct readable orientation, the 4th locking hole was fractured.Under close inspection visually under magnification the fracture surfaces were smooth, reflective, with some gritty/grainy characteristics which is indicative of a brittle fracture caused by a high energy loading event.2 blue anodized screw lengths were both fractured with gritty and grainy markings which confirms a high energy event occurred to cause the failure.A broken screw head denoting batch 515675 (col-3240) was also returned, but cannot be matched up with it's corresponding broken screw shaft.Shaft 1 was returned measuring approximately.93in/23.62mm of material.Shaft 2 was returned measuring approximately.828in/21.03mm of material.All of the remaining screws were intact.All screws showed signs of usage with missing anodization and minor damage during insertion or removal.The root cause of the reported event could not be conclusively determined.

• Brand Name: 2.3 MM X 14 MM HEXALOBE MULTISCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass rd.; hillsboro, OR
• MDR Report Key: 18707932
• MDR Text Key: 335404663
• Report Number: 3025141-2024-00155
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3004-23014-S
• Device Catalogue Number: 3004-23014-S
• Device Lot Number: 481982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2019
• 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