MAUDE Adverse Event Report: CAREFUSION, INC LOVE-GRUENWALD PITUITARY FORCEP 2X10MM; KERRISON RONGEURS

Model Number	NL6147
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).29sep2021 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number 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 or Problem Description
Per complaint details received: jaw portion of the instrument broke off today during one of our physician¿s lumbar case.Broken piece not able to be retrieved.The sample is not available for investigation.No further information available.

• Brand Name: LOVE-GRUENWALD PITUITARY FORCEP 2X10MM
• Common Device Name: KERRISON RONGEURS
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 12667195
• Report Number: 1423507-2021-00045
• Device Sequence Number: 19886607
• Product Code: HAE
• UDI-Device Identifier: 10885403082283
• UDI-Public: (01)10885403082283
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2021
• Report Date (Section F): 10/20/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: NL6147
• Device Catalogue Number: NL6147
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 10/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention