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

Catalog Number	201037
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a hair was found inside the sterilization pack during inspection of a scalp clip (id 201037).The product was stored in a warehouse (distribution center).No patient involvement.
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
N/a.
Additional Manufacturer Narrative
Updated fields - d4, d8, d9, g6, h1, h2, h3, h4, h6, h11.The scalp clip (id 201037) was returned for evaluation.Device history record (dhr) - was reviewed for the reported product¿s lot number.And it was noted that a report was opened, and disposition was to do 100% inspection on material.This issue was not caught during the inspection therefore we have notified supplier.No other anomalies were identified that occurred during the manufacture or packaging of the device.Failure analysis - a visual inspection was conducted on the returned device, and it confirmed presence of a hair on sealed package.Root cause - per the complaint background, hair was found.The complaint was confirmed during investigation and failure analysis evaluation.Debris present in packaging material, a potential root cause is operator error, workstation not clean.

• 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: 22010874
• Report Number: 3014334038-2025-00062
• Device Sequence Number: 12060291
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: Other
• Device Catalogue Number: 201037
• Device Lot Number: 7466351
• 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: 04/18/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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