MAUDE Adverse Event Report: ACUMED LLC 3.5MM X 10MM NON-LOCKING HEXALOBE SCREW; SCREW, FIXATION, BONE

Model Number 30-0256

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

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

Event Type  Injury  

Manufacturer Narrative

The screws that were returned were visually inspected under magnification.All show signs of usage such as surface scratches due insertion or removal.The screw does show additional signs of wear.Towards the head on the shaft the threads are bent and mildly stripped due to stress applied during insertion or removal.Additional mdrs associated with this event: 3025141-2019-00638 follow up 1: plate, 3025141-2019-00667: screw 1, 3025141-2019-00668: screw 2, 3025141-2019-00669: screw 3, 3025141-2019-00670: screw 4, 3025141-2019-00672: screw 6, 3025141-2019-00673: screw 7, 3025141-2019-00674: screw 8, 3025141-2019-00675: screw 9, 3025141-2019-00676: screw 10, 3025141-2019-00678: screw 11, 3025141-2019-00677: screw 12.

Event Description

A distal clavicle plate was implanted into the patient to treat a fractured clavicle.At some point post op, the plate broke.Plate and screws were explanted.

• Brand Name: 3.5MM X 10MM NON-LOCKING HEXALOBE SCREW
• Type of Device: SCREW, 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: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 9569194
• MDR Text Key: 176051231
• Report Number: 3025141-2019-00671
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K102998
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 30-0256
• Device Catalogue Number: 30-0256
• Device Lot Number: 367332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Date Manufacturer Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2015
• 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
• Patient Age: 39 YR
• Patient Weight: 115