MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PETIT-POINT MIXTER FCPS 7-1/4; CARDIOVASCULAR GENERAL

Catalog Number	140223
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/06/2025
Type of Reportable Event	Serious Injury
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
The following information was received via mdr report# mw5164844: "one of the residents was putting in a screw in the hip used a right angleclamp to manipulate a tissue then the tip of the clamp broke off.Both doctors tried to fish out the broken piece of clamp for more than 30min, could not find the piece then decided that it was more risk to take it outthan leaving it in the patient.¿ it is unknown whether an x-ray was performed to confirm presence of foreign body.Additional information has been requested.
Additional Manufacturer Narrative
The petit-point mixter fcps 7-1/4 (140223) was not returned for evaluation after three attempts were made to retrieve the product.Based on lot number obtained, a review of the device history record (dhr) was performed and no abnormalities related to the reported issue were identified.Therefore, a definitive root cause cannot be determined.The provided tracking number does not show completion as of (b)(6) 2025, and per return material authorization (rma), the product was purchased in 2020.The issue of breakage may be the result of wear or rough handling over multiple years of use.
Event or Problem Description
N/a.

• Brand Name: PETIT-POINT MIXTER FCPS 7-1/4
• Common Device Name: CARDIOVASCULAR GENERAL
• 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: 21402290
• Report Number: 3014334038-2025-00018
• Device Sequence Number: 15789058
• Product Code: GEN
• UDI-Device Identifier: 10381780379300
• UDI-Public: 10381780379300
• 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
• Report Date (Section B): 03/14/2025

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: 140223
• Device Lot Number: AC2002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2020
• 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: Other; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male