MAUDE Adverse Event Report: ACUMED LLC DISTAL CLAVICLE PLT 2.3MM 16 HOLE, LEFT; PLATE, FIXATION, BONE

Model Number 70-0124

Device Problem Break (1069)

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

Event Type  Injury  

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.

Manufacturer Narrative

The product was visually inspected under magnification.Holding the plate with the laser markings in the correct readable orientation, the 5th slotted hole from the right (3.5mm non locking hexalobe screw or hex screws are used in the slot) is the confirmed failure point.Under close inspection visually under magnification, the fracture was sheared off, not fatigued.This indicates that a high energy event or too much stress caused the plate to break.Additional mdrs associated with this event: 3025141-2019-00667: screw 1; 3025141-2019-00668: screw 2; 3025141-2019-00669: screw 3; 3025141-2019-00670: screw 4; 3025141-2019-00671: screw 5; 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.

• Brand Name: DISTAL CLAVICLE PLT 2.3MM 16 HOLE, LEFT
• 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: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 9535715
• MDR Text Key: 173218159
• Report Number: 3025141-2019-00638
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K012655
• 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,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70-0124
• Device Catalogue Number: 70-0124
• Device Lot Number: 356707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Date Manufacturer Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2015
• 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