MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER INSTRUMENT; DIA. 14 - TRIAL STEM WITH QUICK CONNECTION

Model Number	9013.02.142
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No lot number nor picture of parts has been provided, therefore review of manufacturing record cannot be performed.The manufacturer will submit a final report as soon as the investigation is completed.
Event or Problem Description
During reverse shoulder arthroplasty surgery performed on (b)(6) 2025, while broaching the humeral canal, the quick connect stem impactor tip (part number 9013.02.142, lot unknown) broke off inside the stem trial as the surgeon was hitting it.Trial stem with the tip of the broach handle remained stuck inside the patient and could not be removed with stem extractor (pn 9013.02.301).Medical team used others instruments at the facility to retrieve the broken and stuck components.No fragments were left in patient.Surgery was prolonged of about 20 minutes due to reported issue but was completed without further complications.No impact on patient has been reported.Patient is female, date of birth (b)(6) 1962.The event occurred in the united states.

• Brand Name: SMR SHOULDER INSTRUMENT
• Common Device Name: DIA. 14 - TRIAL STEM WITH QUICK 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: 23944366
• Report Number: 3008021110-2026-00003
• Device Sequence Number: 16139939
• Product Code: KWT
• UDI-Device Identifier: 08033390122115
• UDI-Public: 8033390122115
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• 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
• Report Date (Section B): 01/02/2026

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: 9013.02.142
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown