MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD RANEYSCLP CLP DSPOSE -200; SCALP CLIPS

Catalog Number	201037
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a physician noticed that the trace of one of the scalp clips (id 201037) was melting before surgery.No patient injury reported.
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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The scalp clips (id 201037) was returned for evaluation.Device history record (dhr) - the reported product¿s lot or serial number.No anomalies were identified that occurred during the manufacture or packaging of the device.Failure analysis - the device appeared melted.This could be due to customer damaged or a manufacturing defect.The complaint can be confirmed.Root cause analysis - potential causes include customer mishandling or manufacturing defect.
Event or Problem Description
N/a.

• Brand Name: RANEYSCLP CLP DSPOSE -200
• Common Device Name: SCALP CLIPS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22098391
• Report Number: 3014334038-2025-00070
• Device Sequence Number: 20921214
• Product Code: HBO
• UDI-Device Identifier: 10381780511625
• UDI-Public: 10381780511625
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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 Catalogue Number: 201037
• Device Lot Number: 7124686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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