MAUDE Adverse Event Report: ACUMED LLC LATERAL FIBULA PLATE 7-H R; PLATE, FIXATION, BONE

Model Number 7007-0107R-S

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

The product was visually inspected under magnification to confirm fracture pattern on the lateral fibula plate.Under close inspection, visually under magnification, the fracture occurred at the 5th hole from the proximal end.The fracture pattern shows mostly a shear force fracture.When holding the plate with laser markings facing towards the viewer, there are spots on the top fracture surface that has some spots along the fracture surface indicating of fatigue.The plate is not bent or twisted out of shape.There are minimal scratches along the surface of the plate.The threads on the hole where the fracture occurred are stripped in areas of their anodization.The predominant fracture pattern indicates a high energy event or too much stress caused the plate to break, first on one side with the clean, transverse fracture, then on the other side where the oblique fracture occurred.

Event Description

A lateral fibula plate was implanted in a patient on (b)(6) 2020.At some point post op, the plate broke.It was explanted on (b)(6) 2021.

• Brand Name: LATERAL FIBULA PLATE 7-H R
• 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: 11630485
• MDR Text Key: 244310799
• Report Number: 3025141-2021-00030
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143394
• 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: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7007-0107R-S
• Device Catalogue Number: 7007-0107R-S
• Device Lot Number: 442601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2018
• 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: 47 YR