MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MAYO-HEGAR NH 6; N/A

Catalog Number	120135
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that when the mayo-hegar needle holder 6 (120135) and needle were placed in the basin after use, the needle holder snapped open and "sent the needle flying across the room".It was reported that there was no patient injury.
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 field: d4 (udi#), d9, g3, g6, h2, h3, h4, h6, h11.The mayo-hegar nh 6 (120135) was returned for evaluation.The device history record (dhr) was reviewed, and no anomalies related to the reported issue were identified.The reported complaint was confirmed: the returned mayo-hegar nhs were received in used condition with staining and wear on the surface.One of the needle holders had misaligned ratchets, allowing the lock to come apart when struck against a table.The misalignment may be due to wear or environmental damage.
Event or Problem Description
N/a.

• Brand Name: MAYO-HEGAR NH 6
• Common Device Name: N/A
• 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: 19553646
• Report Number: 3014334038-2024-00125
• Device Sequence Number: 14655614
• Product Code: FHQ
• UDI-Device Identifier: 10381780377009
• UDI-Public: 10381780377009
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: 120135
• Device Lot Number: AB2311
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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