MAUDE Adverse Event Report: ACUMED LLC 2.3MM X 20MM LOCKING CORTICAL SCREW; SCREW, FIXATION, BONE

Model Number CO-T2320

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

All four distal holes of the plates are filled with the four broken 2.3 mm screws.The smooth and consistent surface of the screw fracture surface is consistent with a single shear overloading event.A large force perpendicular to the screws caused for a shear stress greater than the material could withstand.The absence of beach marks supports the assessment that fatigue stress was not the cause of the fractures.Additional mdrs associated with this event: 3025141-2020-00156: plate, 3025141-2020-00161: screw 1, 3025141-2020-00162: screw 2, 3025141-2020-00163: screw 3, 3025141-2020-00164: screw 4, 3025141-2020-00166: screw 6, 3025141-2020-00167: screw 7, 3025141-2020-00168: screw 8.

Event Description

An aculoc vdr plate was implanted in the patient on (b)(6) 2019.At some point post op, the screws in the distal portion of the plate broke.The broken screws and plate were removed in a revision surgery.

• Brand Name: 2.3MM X 20MM LOCKING CORTICAL SCREW
• 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: micki anderson ; 5885 ne cornelius pass road; hillsboro, or ; 6279957138
• MDR Report Key: 10273817
• MDR Text Key: 198854116
• Report Number: 3025141-2020-00165
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120903
• 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: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CO-T2320
• Device Catalogue Number: CO-T2320
• Device Lot Number: 461941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Date Manufacturer Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2019
• 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): Required Intervention