MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MEDACTA BIPOLAR HEAD 28/53

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Reference imp# (b)(4).

Manufacturer Narrative

Document review: bipolar head 28/53mm: ref.25060.2853 / lot 102238 (3 items produced): all parameters were found to be in accordance with the specifications valid at the time of manufacturing, including washing and sterilization procedures.All the items belonging to this lot have been already sold without any other similar incident.From the data collected, there are no evidences that the infection is device related.

• Brand Name: MEDACTA BIPOLAR HEAD 28/53
• Type of Device: BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; castel san pietro ; SZ
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro ; SZ
• Manufacturer Contact: adam gross ; 1556 w carrol ave; chicago, IL 60607 ; 3128782381
• MDR Report Key: 3674027
• MDR Text Key: 4346262
• Report Number: 3005180920-2014-00006
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K091967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1