MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD NAIL SPLITTER 4 STR; M13 - PODIATRY

Model Number	40-224
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 4 str (40-224) had a possible broken spring.It is unknown under which circumstance this malfunction was discovered; however, no injury, death or surgical delay was reported.
Additional Manufacturer Narrative
The nail splitter (40-224) was returned for evaluation.Device history record (dhr): no lot number was visible on the returned product for dhr review.Failure analysis: evaluation of the returned nail splitter found that the unit was in used condition with the handles and jaws out of alignment and unable to spring properly due to wear.Root cause: the reported complaint was confirmed.The returned nail splitters were observed with the jaws and handles out of alignment due to wear/rough handling/environmental damage, preventing proper spring action.No manufacturing, workmanship or material deficiency has been identified.
Event or Problem Description
N/a.

• Brand Name: NAIL SPLITTER 4 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: 15370636
• Report Number: 3014334038-2022-00194
• Device Sequence Number: 19241418
• Product Code: MDM
• UDI-Device Identifier: 10381780436393
• UDI-Public: 10381780436393
• 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): 10/11/2022

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 Model Number: 40-224
• Device Catalogue Number: 40-224
• 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: 08/10/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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