MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD U-C DETACH KERRISON MICRO 40D UP 8; RUGGLES-REDMOND

Catalog Number	RB5862DT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
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 u-c detach kerrison micro 40d up 8 (rb5862dt) failed (broke) during a surgical case.The broken part was reportedly removed with a surgical grasper.It is unknown whether all broken parts were recovered.No patient injury, death or surgical delay occurred.
Additional Manufacturer Narrative
Updated fields: d4 (lot number, udi#), d9, g3, g6, h2, h3, h6, h8, h11.Corrected field: d4 (serial number).The u-c detach kerrison micro 40d up 8 (rb5862dt) has not been returned for evaluation; however, an image of the reported product was provided.The device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Visual evaluation of the u-c detach kerrison micro 40d up 8 (rb5862dt) was performed.Per the provided image, this kerrison (rb5862dt) had a piece broken off of the jaws.Damage to the jaws may result from rough handling or cutting with dull blades.The product lot number indicates a manufacture date of 2015.Damage and dullness may be the result of wear.The reported complaint was confirmed.No manufacturing, workmanship or material deficiency has been identified.
Event or Problem Description
N/a.

• Brand Name: U-C DETACH KERRISON MICRO 40D UP 8
• Common Device Name: RUGGLES-REDMOND
• 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: 19201252
• Report Number: 3014334038-2024-00091
• Device Sequence Number: 15480372
• Product Code: HAE
• UDI-Device Identifier: 10381780138976
• UDI-Public: 10381780138976
• Combination Product (Y/N): N
• PMA/510(K) Number: K150428
• 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): 06/17/2024

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: RB5862DT
• Device Lot Number: 100161-1507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male