MAUDE Adverse Event Report: OSSUR HF REBOUND POST OP KNEE; JOINT, KNEE, EXTERNAL BRACE

Model Number B-8381480

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

Research to the complaint history of cases identified in total 7 cases related to failure of the second tab of the brace.No injury occurred in any of the cases potential contributing factors to this failure mode have been identified: raw materials: the resin used to mold the plastic components, including the buckle, was changed by the supplier, the new material is slightly less robust than the original material.Design and manufacturing: it was found that the molds used for the production at the manufacturing site slightly differ from the molds used for the products used during design/development and verification testing.(b)(4) has been initiated and corrective and preventive measures were defined.

Event Description

Buckle no 2 broke on the device.No injury occurred.

• Brand Name: REBOUND POST OP KNEE
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): OSSUR HF; grjothals 1-5; reykjavik, 110 ; IC 110
• Manufacturer Contact: katla axelsdottir ; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 8190140
• MDR Text Key: 131334147
• Report Number: 3003764610-2018-00008
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: B-8381480
• Device Catalogue Number: B-8381480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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