MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE GMBH MODULAR EBS KNEE JOINT

Model Number 3R60

Device Problem Device Slipped (1584)

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

Event Type  malfunction  

Manufacturer Narrative

The evaluation was carried out on 12/15/2015.Several bolts are used to fix the different parts of the knee joint when it is mounted.The threads of the bolts are covered with an two-component-adhesive, which is hardening once the bolt is tightened.This is to assure that the parts are fixed permanently.The visual evaluation showed that two of the upper bolts were loose.No fall or injury occurred due to this failure, but it could have led to patient injury.

Event Description

Knee joint was sent in for repair.According to information provided by the customer, screws were loose.No fall, no injury.

• Brand Name: MODULAR EBS KNEE JOINT
• Type of Device: MODULAR EBS KNEE JOINT
• Manufacturer (Section D): OTTO BOCK HEALTHCARE GMBH; max-naeder-str. 15; duderstadt, niedersachsen 37115 ; GM 37115
• Manufacturer (Section G): OTTO BOCK HEALTHCARE GMBH; max-naeder-str. 15; duderstadt, niedersachsen 37115 ; GM 37115
• Manufacturer Contact: dominik schmidt ; max-naeder-str. 15; duderstadt, niedersachsen 37115 ; GM 37115 ; 9552784816
• MDR Report Key: 5301519
• MDR Text Key: 34275191
• Report Number: 9616494-2015-00015
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Reporter Country Code: LH
• 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: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3R60
• Device Catalogue Number: 3R60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1