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

Model Number	NL6147
Medical Device Problem Codes	Break (1069); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mw5099486 - pr # (b)(4), 02apr2021 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 attached complaint details from mw5099486: dr was using clamp to remove the head of the femur due during the surgical case.The jaws broke and was retrieved using c-arm fda safety report id# (b)(4).It was reported that instrument broke during surgery and retrieved via c-arm.07apr2021 customer response: what is the lot number? i do not see a lot number on this instrument.Please confirm whether or not there was any patient injury.There was no harm to the patient that i am aware of.No further information available.
Additional Manufacturer Narrative
Follow up 2693940.The sample was provided, and an evaluation was performed.The root cause is overstressing of the instrument.The jaw has been torn off and bent on the almost 13-year-old instrument.There have been no issues identified with the material or manufacturing process.The product has been manufactured and tested according to the specifications.H3 other text : see h10.
Event or Problem Description
Per attached complaint details from mw5099486: dr was using clamp to remove the head of the femur due during the surgical case.The jaws broke and was retrieved using c-arm fda safety report id# (b)(4).It was reported that instrument broke during surgery and retrieved via c-arm.(b)(6) 2021 customer response: what is the lot number? i do not see a lot number on this instrument.Please confirm whether or not there was any patient injury.There was no harm to the patient that i am aware of.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: 11675248
• Report Number: 1423507-2021-00026
• Device Sequence Number: 3617457
• Product Code: HAE
• UDI-Device Identifier: 10885403082283
• UDI-Public: (01)10885403082283
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021
• Report Date (Section F): 03/25/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NL6147
• Device Catalogue Number: NL6147
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: Yes
• Device Age: 13 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2021
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 06/25/2021
• 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
• Date Report Sent to FDA: 03/25/2021