MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD TUFFIER RIB SPREADER SCORED; CARDIOVASCULAR RETRACTORS

Catalog Number	300150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the retractor/tuffier rib spreader scored) broke during open decortication of right lung."the knob that allows for the opening of the retractor broke off.The retractor was immediately removed.All the pieces were retrieved.The surgeon had to cut a piece of rib off in order to sequester all the pieces.Once the pieces were retrieved, the device was placed off the sterile field and bagged." it was reported that there was an unspecified delay in procedure due to the product problem.A different retractor was used to complete the case.An x-ray was reportedly performed in the intensive care unit (icu), as the piece broke off cleanly.".
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
N/a.
Additional Manufacturer Narrative
Updated field -d9, g3, g6, h2, h3, h6, h11.300150 tuffier rib spreader scrd was returned for evaluation.Failure analysis - the evaluation of the returned 300150 rib spreader is in used condition with damage and rust along the surface.The lot number was not visible on the product, indicating a manufacture date prior to 2018 or significant wear to the etching.The handle was broken off and the screw it attached to was deformed by force.The inside of the handle was rusted.Breakage may have been the result of corrosion to the device due to wear, leading to difficulty turning the handle.Difficulty turning the handle may have led the user to apply excessive force, causing deformation and breakage of the screw.The lot number was not available for dhr review.Root cause - the reported complaint is confirmed.The damages and rust along the surface may be the result of wear over several years of use.No manufacturing, workmanship, or material deficiency has been identified.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.Additional field: h6 (investigation findings 1).Corrected fields: h1 (corrected from follow-up 1).

• Brand Name: TUFFIER RIB SPREADER SCORED
• Common Device Name: CARDIOVASCULAR RETRACTORS
• 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: 21679235
• Report Number: 3014334038-2025-00042
• Device Sequence Number: 21159285
• Product Code: GAD
• UDI-Device Identifier: 10381780456377
• UDI-Public: 10381780456377
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 300150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 03/24/2025; 04/24/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 04/22/2025; 05/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown