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	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Checking the manufacturing charts of the instrument involved, no pre-existing anomaly was discovered on the items manufactured with the same lot number.We will submit a final report as soon as the investigation is complete.
Event or Problem Description
Intra-operative issue occurred during an elbow revision surgery performed on (b)(6)2024.The screwdriver shaft for axle (part code 9015.90.006, lot number 23bq096) broke while trying to remove the axle.Midas cutting tool was used to cut implant for removal.The instrument was used for the first time.The related post-operative issue was registered as internal complaint (b)(4) and reported to the fda with mfr 3008021110-2024-00073.Event happened in the united states.

• 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: 20358667
• Report Number: 3008021110-2024-00078
• Device Sequence Number: 7208944
• 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: 10/03/2024
• 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