MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM STR CONN S/S; CONNECTORS

Model Number	82-3048
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint sample was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.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.The customer reported: "inconsistency between the ifu labels for 2 products and their respective drawing specifications".-a study by product development team concluded that inconsistency in dimensions between ifu and drawings exists, but is "subtle" (the order of magnitude is the tenth of a millimeter).-the root cause for this reported issue was probably due to interpretation error of the drawings dimensions.But due to the very low error level, the fact that "customers do not really have any issues with the product", the elastic properties of the silicone catheters and there is no possibility of patient harm, therefore this issue was deemed "negligible" and changing dimensions on ifu was considered as "not necessary".-complaint will be closed as 'incorrect/inadequate labeling: without possibility of patient harm'.
Event or Problem Description
1 of 2 reports.Other mfg report number: 3013886523-2021-00235.A facility reported the instructions for use for the hakim connectors has different drawings dimensions for sku 823048 and 823049.No patient contact/injury reported and the event did not led to surgical delay.

• Brand Name: HAKIM STR CONN S/S
• Common Device Name: CONNECTORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11900448
• Report Number: 3013886523-2021-00234
• Device Sequence Number: 4379440
• Product Code: JXG
• UDI-Device Identifier: 10886704041283
• UDI-Public: (01)10886704041283
• Combination Product (Y/N): N
• PMA/510(K) Number: K102961
• 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
• Report Date (Section B): 05/28/2021

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: 82-3048
• Device Catalogue Number: 823048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1