MAUDE Adverse Event Report: CAREFUSION, INC CRILE MICRO ARTERY FORCEPS DEL CVD 5-1/2; GENERAL & PLASTIC SURGERY

Model Number SU2734

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/28/2023

Event Type  malfunction  

Manufacturer Narrative

Medwatch # mw5117383 submitted by customer.Pr # (b)(4).(b)(6) 2023 writer sent the customer an email acknowledging receipt of the complaint and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.

Event Description

Material #: su2734, batch #: l17xmrce.It was reported by the customer that the tip of hemostat broke off during surgery.Verbatim: tip of hemostat broke off during surgery.Guide pin was being placed into same area and hemostat tip was struck, sheared off, retrieved.Was not left in patient's knee.No harm to patient.X-ray taken and confirmed no pieces or parts of hemostat was left inside the patient's knee.Additional information received on 16-may-2023.Are you able to provide the occurrences of the incident? date of occurrence: (b)(6) 2023, tip of hemostat sheared off during surgery, retrieved, enclosed in biohazard bag with instrument are you able to confirm the batch number [l17xmrce] is the correct batch number since it was not detected in our system for product number su2734? do not have supply information in risk management do you have photos showing the reported issue? attached is the product available to send back to us for an evaluation? if so, please provide your address and a prepaid fedex label will be provided.Yes¿risk management at (b)(6).Att: (b)(6).What is the full name and address of the facility for where the issue occurred? (b)(6).

Event Description

Material #: su2734 batch #: l17xmrce it was reported by the customer that the tip of hemostat broke off during surgery.Verbatim: tip of hemostat broke off during surgery.Guide pin was being placed into same area and hemostat tip was struck, sheared off, retrieved.Was not left in patient's knee.No harm to patient.X-ray taken and confirmed no pieces or parts of hemostat was left inside the patient's knee.Additional information received on 16-may-2023.1.Are you able to provide the occurrences of the incident? date of occurrence: (b)(6) 2023, tip of hemostat sheared off during surgery, retrieved, enclosed in biohazard bag with instrument 2.Are you able to confirm the batch number [l17xmrce] is the correct batch number since it was not detected in our system for product number su2734? do not have supply information in risk management 3.Do you have photos showing the reported issue? attached 4.Is the product available to send back to us for an evaluation? if so, please provide your address and a prepaid fedex label will be provided.Yes¿risk management at grant medical center att: (b)(6) what is the full name and address of the facility for where the issue occurred? (b)(6).

Manufacturer Narrative

Follow up mdr for 7933548 the sample was provided, and an evaluation was performed.The root cause is overstressing of the instrument.The instrument was examined using a microscope.From the hardness test and the quality of the broken surface, we can determine that the hardness and material structure of the instrument are within specification.The hardness value is within the international and bd tolerances.The surface of the broken part is fine-grained, so the softening after the heat treatment was also good and proper.If there had been a crack in the instrument due to fitting or setting processes, discoloration or other differences in surface quality would be visible on the broken surface.We can determine that the instrument did not break due to a material defect or a manufacturing defect.However, during the examination, we discovered traces of damage to the teeth inside the jaw.This shows compression and lateral tension of a material harder than the material of the hemostatic forceps, as there are lateral pressures on the surface of the instrument.It is likely that the user clamped an object harder than the forceps and made it to twisting stress.This can also be seen on the broken surface, that the break started from the side, without any prior cracking.The product would have been manufactured and tested according to the specifications.A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.

• Brand Name: CRILE MICRO ARTERY FORCEPS DEL CVD 5-1/2
• Type of Device: GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 17039296
• MDR Text Key: 316317598
• Report Number: 1423507-2023-00092
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 10885403064203
• UDI-Public: (01)10885403064203
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2023,07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SU2734
• Device Catalogue Number: SU2734
• Device Lot Number: L17XMRCE
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2023
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2023
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention