MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION 15X20MM BIOMEND; DENTAL PRODUCTS

Catalog Number	0103
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
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
A distributor reported an unopened sterile biomend (0103p) contained a hair.No patient involvement.
Additional Manufacturer Narrative
The biomend (0103p) was returned for evaluation.Device history record (dhr) - the device history record (dhr) of the reported fg lot number 6912357 was reviewed and no anomalies were found during manufacturing and packaging processes of the lot which could contribute and/or be related to the reported condition.Failure analysis - the reported catalog and lot number were confirmed.The unit was visually inspected, and a hair was observed inside the tray on top of the tyvek envelope containing the unit.Retain samples evaluation: nine (9) units (1 shipper box with 9 dispenser boxes) were visually inspected.Dispenser boxes and product trays are in good condition.Tray sealing area was complete.No foreign matter was observed on the inspected unit.Based on the evaluation of the returned unit, the complaint is considered confirmed.Root cause analysis - the root cause for the reported condition is that manufacturing personnel failed to identify the foreign material during the 100% visual inspection after the tray sealing process.An awareness training was provided to manufacturing personnel to discuss the complaint and emphasize the importance of being aware of the gowning and inspection practices (to observe the samples from different angles).Also, the returned unit was shown to the personnel so they could see where the hair was located which could not be seen unless the tray was turned sideways.This is the first complaint related to foreign matter in the periodontal regeneration product family for the past 24 months.

• Brand Name: 15X20MM BIOMEND
• Common Device Name: DENTAL PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; plainsboro NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18065795
• Report Number: 2648988-2023-00034
• Device Sequence Number: 7815405
• Product Code: LYC
• UDI-Device Identifier: 10381780070733
• UDI-Public: 10381780070733
• Combination Product (Y/N): N
• PMA/510(K) Number: K992216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: 0103
• Device Lot Number: 6912357
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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