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

Model Number	NL7100-040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1423507-2022-00008
• Device Sequence Number: 4612908
• Product Code: HTX
• UDI-Device Identifier: 10885403083624
• UDI-Public: (01)10885403083624
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/10/2022
• Report Date (Section F): 03/23/2022

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?: Yes
• Operator of Device: 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
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/23/2022