MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SILVERS MINI SKIN GRAFT KNIFE; SKIN GRAFT PRODUCTS

Model Number	P14701
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	01/05/2023
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
It was reported that the silvers mini skin graft knife (p14701) was opened by the customer."a blade was loaded; customer didn't realize it, as it is not supposed to come with blades." the nurse suffered a minor skin abrasion: skin cells lost, no blood loss, and no stitches required.The device was not in contact with a patient; thus, no patient injury or surgical delay occurred.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The silvers mini skin graft knife (p14701) was returned for evaluation.The device history record (dhr) was reviewed, and no anomalies related to the reported failure were identified.Failure analysis: the silvers mini skin graft knife was received in unused condition with no visible defect.The blade was not present.Per the drawing, this product is sold with a blade in its packaging.Root cause analysis: the reported complaint was confirmed.Per specifications, this product is sold with a blade in the packaging.This complaint may be the result of older iterations of the product not containing the blade.No manufacturing, workmanship or material deficiency has been identified.

• Brand Name: SILVERS MINI SKIN GRAFT KNIFE
• Common Device Name: SKIN GRAFT PRODUCTS
• 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: 16274789
• Report Number: 3014334038-2023-00009
• Device Sequence Number: 12437690
• Product Code: EMF
• UDI-Device Identifier: 10381780212478
• UDI-Public: 10381780212478
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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: P14701
• Device Catalogue Number: P14701
• Device Lot Number: AE2209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• 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