MAUDE Adverse Event Report: OSSUR MEXICO INNOVATOR X; ELBOW BRACE

Catalog Number W-823100

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Discomfort (2330)

Event Date 10/30/2020

Event Type  Injury  

Event Description

The patient had surgery on a torn biceps in (b)(6) 2020.After a few weeks casting the innovator x was fitted on the arm.Later that day the patient was startled by something and stretched his right elbow, causing the lock to loosen.Patient indicated that brace is very uncomfortable during use and he is not happy with the brace in general.

Manufacturer Narrative

Ifu provides instructions that after the range of motion adjustment in step 8 for "enforced compliance: loop and secure the enclosed lock ties through the holes in the flexion and extension buttons to limit range of motion adjustment." no field action, correction, or removal is required as this is considered use error, where the zip ties weren't installed and this is the first reported occurrence of sharp edges.The ifu provides clear instruction that zip ties were to be installed after the range of motion was appropriately adjusted.Trend analysis: (b)(4).Sales: 141,885.Rom inadequate: 1.Sharp edge: 1.P1 (rom): 1/141885 = 7.05e-06.P1 (sharp edge): 1/141885 = 7.05e-06.

Event Description

The patient had surgery on a torn biceps on (b)(6) 2020.After a few weeks casting the brace was fitted on the arm.Later that day the patient was startled by something and stretched his right elbow, causing the lock to loosen due to use error as the zip ties weren't installed to prevent unintended increase of motion.The patient tore his biceps again, and it is not possible to undergo a second operation.As a result, the patient has limited strength in his arm.He may regain a certain degree of strength and mobility with enough physical therapy.Patient indicated that brace is very uncomfortable during use and he is not happy with the brace in general.

• Brand Name: INNOVATOR X
• Type of Device: ELBOW BRACE
• Manufacturer (Section D): OSSUR MEXICO; blvd. hector teran teran 2102; build.#1 col. canon del padre; tijuana, baja california 22206 ; MX 22206
• MDR Report Key: 11048020
• MDR Text Key: 223618073
• Report Number: 3008523132-2020-00002
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: W-823100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability