MAUDE Adverse Event Report: LIMACORPORATE S.P.A TEMA ELBOW; T15 SCREWDRIVER SHAFT WITH ZIMMER CONNECTION

Model Number	9015.90.006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Intra-operative issue occurred during an elbow surgery performed on (b)(6) 2025.The surgeon tried linking implants using axle on a total elbow arthroplasty and tip of driver broke inside the axle while trying to implant.No broken pieces were left in the patient.The instrument involved in this event is the following: - screwdriver shaft for axle (part code 9015.90.006, lot number 23bq096) the event happened in the united states.
Additional Manufacturer Narrative
Checking the manufacturing charts of the instrument involved in this event, no pre-existing anomaly was discovered in the items belonging to the same part code and lot number.The manufacturer will submit a final mdr as soon as the investigation is complete.

• Brand Name: TEMA ELBOW
• Common Device Name: T15 SCREWDRIVER SHAFT WITH ZIMMER CONNECTION
• 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: 22694126
• Report Number: 3008021110-2025-00103
• Device Sequence Number: 8958956
• Product Code: LXH
• UDI-Device Identifier: 08033390207935
• UDI-Public: 8033390207935
• 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): 05/21/2026

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: 9015.90.006
• Device Lot Number: 23BQ096
• 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: 08/02/2025
• Supplement Report FDA Received Date: 05/25/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown