MAUDE Adverse Event Report: CAREFUSION, INC DAWSON-YUHL-LEKSELL RONG FORCEPS 5X13MM; RONGEURS

Model Number NL7100-040

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2022

Event Type  malfunction  

Event Description

Per complaint details received: it was reported that product separated into two pieces while in use during procedure.Srg-dawson-yuhl-leksell rong forceps 5x13mm-nl7100-040.Email verbatim: describe the event or problem: leksell rongeur separated into two pieces while in use during procedure.One small metal piece was determined to be missing, but surgical tech was unsure whether the instrument was broken prior to the case started or if it actually broke while in use during the case.Surgical field searched, surrounding bed/floor/table searched, x-ray taken without locating missing metal piece.Radiologist confirmed no retained foreign objects present in wound.No further information available.

Manufacturer Narrative

(b)(4).(b)(6) 2022 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.

• Brand Name: DAWSON-YUHL-LEKSELL RONG FORCEPS 5X13MM
• Type of Device: RONGEURS
• 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: 13869268
• MDR Text Key: 297970913
• Report Number: 1423507-2022-00008
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 10885403083624
• UDI-Public: (01)10885403083624
• 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: Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/23/2022,03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL7100-040
• Device Catalogue Number: NL7100-040
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2022
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other