MAUDE Adverse Event Report: LIMACORPORATE S.P.A. CANCELLOUS SCREWS; BONE SCREWS DIA. 6.5 X H. 15 MM

Model Number	8420.15.005
Medical Device Problem Codes	Break (1069); Degraded (1153); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts of the components involved in this event, no pre-existing anomaly was discovered in the items belonging to the same part code and lot number as the devices removed in the revision surgery hereby reported.The manufacturer will submit the final mdr as soon as the investigation is complete.
Event or Problem Description
Shoulder revision surgery was performed on (b)(6) 2025.During revision procedure, the liner was removed and examined (smr reverse liner standard, part code 1360.50.810, lot number 20at0xn, sterilization (b)(4)), not showing significant or unusual signs of wear.The reverse body was left in place because it was determined that removing would threaten to fracture tuberosities.Glenosphere (smr eccent.Glenosphere ø 36mm, part code 1376.09.031, lot number 2009277, sterilization (b)(4)) and bone screws (bone screw ø6,5 h.15mm, part code 8420.15.005, lot number 1802866, sterilization (b)(4); bone screw ø6,5 h.20mm, part code 8420.15.010, lot number 2006407, sterilization (b)(4); bone screw ø6,5 h.40mm, part code 8420.15.050, lot number 2006421, sterilization (b)(4)) were removed.At this point, the baseplate (tt augm.360 baseplate #s-r+2mm, part code 1375.15.522, lot number 2008603, sterilization (b)(4)) could be pulled out by hand with hemostats.During removal of screws, it was noted that there were metal shavings (apparently from the screws) left behind the baseplate.It was hypothesized that this debris may have been created while implanting the screws at too aggressive of an angle.Previous surgery took place on (b)(6) 2020.The patient is a female, date of birth (b)(6) 1946.The event happened in the united states.

• Brand Name: CANCELLOUS SCREWS
• Common Device Name: BONE SCREWS DIA. 6.5 X H. 15 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 daniele, udine 33038
• MDR Report Key: 23579327
• Report Number: 3008021110-2025-00148
• Device Sequence Number: 9222786
• Product Code: LPH
• UDI-Device Identifier: 08033390110693
• UDI-Public: 08033390110693
• Combination Product (Y/N): N
• PMA/510(K) Number: K172456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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
• Device Model Number: 8420.15.005
• Device Lot Number: 1802866
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown