MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMER; HAKIM PROGRAMMING TOOLS

Model Number	82-3190
Medical Device Problem Codes	Overheating of Device (1437); Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported the hakim programmer stopped working, overheated and would not allow setting to be selected.No patient injury reported.
Additional Manufacturer Narrative
Updated fields:  d4, d9, g3, g6, h2, h3, h4, h6, h10.The hakim programmer (id 823190) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined; however, the possible root cause for this issue reported by the customer could be due to normal wear out, as the device was manufactured in 2004.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: HAKIM PROGRAMMER
• Common Device Name: HAKIM PROGRAMMING TOOLS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 11254847
• Report Number: 3013886523-2021-00049
• Device Sequence Number: 11638379
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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: 1186510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 04/12/2022
• Date Device Manufactured: 04/08/2004
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown