MAUDE Adverse Event Report: OSSUR HF REBOUND; REBOUND CRT LEFT MEDIAL SM

Model Number B-254610002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

Patient outcome: developed a foot drop at the left after wearing the brace.Nerve conduction studies confirmed demyelination and axonal damage at the level of the fibular head.Improvement has been reported which gives good hope that the nerves are recovering, it is however yet unclear whether the patient will reach full recovery.Analysis: at the review in the clinic, the patient demonstrated donning of the brace.It was noticed that the brace was fitted lower and slightly rotated.Foot drop was likely caused by pressure from the cartilage protection strap on the common peroneal nerve.The rebound cartilage uses a strapping system similar to that found on the unloader oa knee products (fit, indicator, lite, original, and smart dosing).There have been no instances of similar events on any rebound cartilage or unloader oa knee products.No manufacturing failure or product malfunction could be identified.Based on information provided about brace being fitted lower and slightly rotated, root cause is thought to be due to user having incorrectly positioned brace during donning or brace may have migrated during use.As no confirmation or evidence of product malfunction could be found, no nc, capa, or field action is necessary based on the number of identified product malfunction and low occurrence rate.We will continue to monitor.No concerns or risks for users of this product in the field could be identified at this point, no corrective/preventive considered warranted at this moment.Patient had worn the brace of a few occasions prior to the foot drop occurring.This gives further reason to believe the product was fitted correctly in first instance, but that re-fitting by the patient in a later instance caused the issue.The ifu gives clear instructions, including the following: "caution the rebound® cartilage is field adaptable to accommodate patient comfort issues.Modifications to flexion or extension stops, hinge and shell contour should only be made by the health care professional.The healthcare professional is responsible for advising patient on use of the cartilage protection strap¿." the ifu referred to is enclosed with this report.A reminder to these instructions have been provided to the healthcare professional who has fitted the brace.

Event Description

Patient wore the brace for about 4.5 hrs, using the same settings as set by clinician, and developed foot drop on the left when patient took the brace off.

• Brand Name: REBOUND
• Type of Device: REBOUND CRT LEFT MEDIAL SM
• Manufacturer (Section D): OSSUR HF; 27051 towne centre drive; foothill ranch, 92610
• Manufacturer Contact: crystal swafford ; 27051 towne centre drive; foothill ranch, CA 92610 ; 9493823817
• MDR Report Key: 7820449
• MDR Text Key: 118394205
• Report Number: 3003764610-2018-00001
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: B-254610002
• Device Lot Number: EU151515
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Other
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability