MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CRANIAL HAND DRILL; CUTTERS

Catalog Number	826607
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported they found hairs in sterile packaging of a cranial hand drill (id 826607).Issue detected before product use and the procedure was completed with a replacement product available.No patient consequences.
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 cranial hand drill was returned for evaluation: dhr - the batch record was reviewed for any anomalies or ncs related to the finished device, and none were identified.Failure analysis - the hand drill was visually inspected.A hair was observed inside the unopened packaging.Based on the failure analysis evaluation, we were able to confirm the complaint.Root cause - per the complaint background hairs in sterile packaging, complaint was confirmed in the complaint investigation and failure analysis.A potential root cause is operator error while performing the visual inspection after sealing.

• Brand Name: CRANIAL HAND DRILL
• Common Device Name: CUTTERS
• 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: 20212892
• Report Number: 3014334038-2024-00190
• Device Sequence Number: 7328433
• Product Code: GWM
• UDI-Device Identifier: 10381780520337
• UDI-Public: 10381780520337
• Combination Product (Y/N): N
• PMA/510(K) Number: K914479
• 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): 10/27/2025

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: 826607
• Device Lot Number: 7396468
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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