MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD RUGGLES DISTRACTION SCREW STERILE 14MM; RETRACTORS

Catalog Number	R6398A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The ruggles distraction screw sterile 14mm (r6398a) was not returned for evaluation after three good faith attempts (gfes) were made.The lot number information has been provided; therefore, device history records (dhr) was reviewed, and no anomalies were found.Due to the nature of this complaint, a review of the product id and lot number was performed.No complaints were found in the past 12 months for either the product id or lot; however, a further lookback found a similar complaint on february 06, 2024.This complaint was for a different lot number, and the investigation determined the most likely root cause to be use error (over torque causing the screw to break).Based on this analysis, despite the lack of pictures or return of the product, this complaint is also most likely caused by use error (over torque causing the screw to break).
Event or Problem Description
N/a.
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 during a spinal case, the ruggles distraction screw sterile 14mm (r6398a) distractor broke, and the screw parts were left in the patient.There was no patient injury or surgical delay reported.

• Brand Name: RUGGLES DISTRACTION SCREW STERILE 14MM
• Common Device Name: 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: 23584391
• Report Number: 3014334038-2025-00145
• Device Sequence Number: 9259884
• Product Code: LXH
• UDI-Device Identifier: 10381780025382
• UDI-Public: 10381780025382
• 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): 01/08/2026

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 Catalogue Number: R6398A
• Device Lot Number: 7537047
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2025
• 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