MAUDE Adverse Event Report: CAREFUSION, INC LOVE-GRUENWALD FORCEP 3X10MM CUP STR 5IN; KERRISON RONGEURS

Catalog Number NL6092

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

Pr # (b)(4) on (b)(4) 2019 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 Description

Via regulatory maude report: during revision of a knee replacement, the upper portion of the jaw of a v mueller nl6092 pituitary forcep broke.The broken portion of the instrument was retrieved.Fda safety report id#.On 11jun2019 additional information: what was the procedure that was being performed? revision of total knee replacement.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? yes.Retrieved with forcep.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? it was seen breaking and falling into the femoral canal, and then immediately retrieved.What was the patient¿s outcome? no issues immediately observed.Was the procedure completed as planned? yes.Can you please send all parts of the instrument for evaluation? yes.Do you have the lot number? possibly, xmee 12.No further information available.

Event Description

Via regulatory maude report: during revision of a knee replacement, the upper portion of the jaw of a v mueller nl6092 pituitary forcep broke.The broken portion of the instrument was retrieved.Fda safety report id#.11jun2019 additional information: 1.What was the procedure that was being performed? revision of total knee replacement.2.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? yes.Retrieved with forcep.3.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? it was seen breaking and falling into the femoral canal, and then immediately retrieved.4.What was the patient¿s outcome? no issues immediately observed.5.Was the procedure completed as planned? yes.6.Can you please send all parts of the instrument for evaluation? yes.7.Do you have the lot number? possibly, xmee 12.No further information available.

Manufacturer Narrative

Pr # 1000273 follow up mdr - the sample was provided, and an evaluation was performed.The root cause is overstressing of the 13-year-old instrument.The hardness was tested at 47.1 hrc, which is inside the tolerance of 43-48 hrc.Notches in the cutting edge indicate that the instrument may have been dull and thus have been overstressed.There have been no issues identified with the material or manufacturing process.The product has been manufactured and tested according to the specifications.

• Brand Name: LOVE-GRUENWALD FORCEP 3X10MM CUP STR 5IN
• Type of Device: KERRISON RONGEURS
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 8716540
• MDR Text Key: 149014063
• Report Number: 1423507-2019-00010
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: NL6092
• Device Lot Number: XMEE12
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 06/10/2019
• Supplement Dates FDA Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other