MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD NAIL SPLITTER 5 STR; M13 - PODIATRY

Model Number	40-226-SS
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	12/26/2022
Type of Reportable Event	Serious 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.
Event or Problem Description
A facility reported that the nail splitter 5 str (40-226-ss) failed during use in the debridement of thick fungal toe nails.The product reportedly "failed at their hinge as can be examined and inspected the metal failed".The device was in contact with the patient; however, no patient injury occurred.It was reported that the user obtained another pair and finished the care "with only bruising" of the hand noticed later.No surgical delay was reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The nail splitter 5 str (40-226-ss) was returned for evaluation.The device history record (dhr) was reviewed, and no anomalies related to the reported failure were identified.The reported complaint was confirmed.The nail splitter was received in used condition with one of the handles broken off due to rough handling/environmental damage.The lot number indicates a manufacture date of 2018.The damage may have occurred due to wear over five years.No manufacturing, workmanship or material deficiency has been identified.

• Brand Name: NAIL SPLITTER 5 STR
• Common Device Name: M13 - PODIATRY
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16413334
• Report Number: 3014334038-2023-00017
• Device Sequence Number: 14284693
• Product Code: MDM
• UDI-Device Identifier: 10381780436430
• UDI-Public: 10381780436430
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 40-226-SS
• Device Catalogue Number: 40-226-SS
• Device Lot Number: 100089-1809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2018
• 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