MAUDE Adverse Event Report: LIMACORPORATE S.P.A TEMA ELBOW; T15 SCREWDRIVER SHAFT FOR AXLE REMOVAL

Model Number	9015.90.008
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Checking the manufacturing charts of the instrument involved in this event, no pre-existing anomaly was found in the 9 items belonging to the lot number: 24bh0jb.The manufacturer will submit a final mdr as soon as the investigation is complete.
Event or Problem Description
Elbow revision surgery performed on (b)(6) 2025, due to disassociation of components.Humeral body with safety screw disengaged from modular spacer.This revision is registered as internal complaint: (b)(4) and reported to the fda with mfr.3008021110-2025-00115.During the revision surgery, the tip of the following revision/conversion axle extractor driver broke inside the axle previously implanted while trying to implant new one: t15 screwdr.Shaft f.Axle remov (part code 9015.90.008, lot number: 24bh0jb).Moreover, a driver for 2nm torque limiter used for final implant assembly broke in implanting the new axle: this event is registered as internal complaint: (b)(4) and reported to the fda with mfr.3008021110-2025-00121.We did not receive any additional information about the patient.The event happened in the united states.

• Brand Name: TEMA ELBOW
• Common Device Name: T15 SCREWDRIVER SHAFT FOR AXLE REMOVAL
• 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: 23082087
• Report Number: 3008021110-2025-00117
• Device Sequence Number: 4966198
• Product Code: LXH
• UDI-Device Identifier: 08033390290654
• UDI-Public: 08033390290654
• Combination Product (Y/N): N
• PMA/510(K) Number: 510K EXEMPT
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2026

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: 9015.90.008
• Device Lot Number: 24BH0JB
• 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: 09/18/2025
• Supplement Report FDA Received Date: 05/25/2026
• 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