MAUDE Adverse Event Report: LIMACORPORATE S.P.A. AMF REVISION TT CONES; AMF REVISION TT CONES - CENTRAL TIBIA REAMER HEAD DIA. 18 MM

Model Number	906C.21.818
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Checking the manufacturing charts of the lot numbers involved in the complaint, no pre-existing anomaly has been found out.A final mdr will be submitted as soon as the investigation is completed.
Event or Problem Description
Intra-operative issue due to breakage happened on (b)(6) 2024.It was not the first time it was used; the consignment set involved has been used probably 5-10 times.The instruments involved in the event are the following: reaming shaft (part code 906c.10.800, lot number 22bq01y).Central tibia reamer head d.18 (part code 906c.21.818, lot 22bg037).There was no impact on surgery (about 10 minutes delay) and the surgeon was able to work around it, because when the shaft went through the reamer, he had completed reaming and was able to place the implant.The patient is a female, date of birth (b)(6) 1952.The event happened in the united states.
Event or Problem Description
Intra-operative issue due to breakage happened on (b)(6) 2024.It was not the first time it was used; the consignment set involved has been used probably 5-10 times.The instruments involved in the event are the following: reaming shaft (part code 906c.10.800, lot number 22bq01y), central tibia reamer head d.18 (part code 906c.21.818, lot 22bg037).There was no impact on surgery (about 10 minutes delay) and the surgeon was able to work around it, because when the shaft went through the reamer, he had completed reaming and was able to place the implant.The patient is a female, date of birth (b)(6)1952.The event happened in the united states.
Additional Manufacturer Narrative
Investigation: checking the manufacturing charts of the lot numbers involved in the complaint, no pre-existing anomaly has been found out.The two instruments involved in the event have been returned to the manufacturer for further investigation.The technical department of the manufacturer performed a test with the instruments received, assembling them according to the surgical technique, without observing any malfunction.To deepen the event, the manufacturer decided to retrieve two other instruments, belonging to the same product codes and lot numbers as the complained ones, in order to perform a comparative test of the mechanical behavior.The test performed highlighted that there was no difference in mechanical behavior of the instruments complained and those retrieved internally, as all of them work without showing any kind of malfunctioning.Therefore, the malfunctioning found could not be reproduced.Hence, considering that: no pre-existing anomaly has been discovered by checking the manufacturing charts of the instruments involved in the complaint.According to the functional test performed, no malfunctions of the instruments has occurred.We can conclude that the event is not product related.Pms data: according to our pms data, we can estimate the breakage rate of the instrument reaming shaft to be around (b)(4) (ww), and the breakage rate of the instrument central tibia reamer head d.18 to be around (b)(4) (ww).Please note that this occurrence rate is overestimated because it does not consider the reuse of the instruments but only the total number of pieces manufactured.Based on the root cause analysis performed and according to the relevant pms data, no corrective action is required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

• Brand Name: AMF REVISION TT CONES
• Common Device Name: AMF REVISION TT CONES - CENTRAL TIBIA REAMER HEAD DIA. 18 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san danlele, udine 33038
• MDR Report Key: 19746262
• Report Number: 3008021110-2024-00058
• Device Sequence Number: 18361628
• Product Code: MBH
• UDI-Device Identifier: 08033390189569
• UDI-Public: 08033390189569
• Combination Product (Y/N): N
• PMA/510(K) Number: K200653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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 Model Number: 906C.21.818
• Device Lot Number: 22BG037
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 11/05/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown