MAUDE Adverse Event Report: CODMAN & SHURTLEFF INC. HAKIM PROGRAMMER; HAKIM PROGRAMMING TOOLS

Model Number	82-3190
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to our supplier, but as this device (with a serial number less than 7000) is not eligible to repair, investigation site asked them to not send it to us.The issue of the complaint could not be confirmed as the device has not been received (device obsolete, non eligible to repair) but as the device is very old, we can consider that this issue was due to normal wear out.
Event or Problem Description
A facility reported the hakim programmer overheats and the value could not be adjusted.The issue was detected pre-operatively and no surgical delay was reported.

• Brand Name: HAKIM PROGRAMMER
• Common Device Name: HAKIM PROGRAMMING TOOLS
• Manufacturer (Section D): CODMAN & SHURTLEFF INC.; 325 paramount drive; 325 paramount drive; raynham NJ
• MDR Report Key: 11510110
• Report Number: 3013886523-2021-00118
• Device Sequence Number: 4075594
• Product Code: JXG
• UDI-Device Identifier: 10886704041597
• UDI-Public: 10886704041597
• Combination Product (Y/N): N
• PMA/510(K) Number: K003564
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 82-3190
• Device Catalogue Number: 823190
• Device Lot Number: 1268608
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1