MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; EXPANSION EXTRACTOR

Model Number	EXPANSION EXTRACTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a shoulder revision surgery performed on (b)(6) 2025, when using the smr - expansion extractor (product code 9013.52.165, lot #15aa052).When using the er removal tool for the humeral adaptor, the pegs were not straight.It ended up breaking off at the end.Surgical time extended by 20 minutes.The surgical time was extended by 20 minutes due to the issue.Event happened in australia.
Additional Manufacturer Narrative
Checking the manufacturing charts of the involved lot #15aa052, no pre-existing anomaly was found on the (b)(4) devices manufactured with the same lot #.We submit a final mdr when the investigation is complete.
Additional Manufacturer Narrative
Investigation: checking the manufacturing charts of the involved lot #15aa052, no pre-existing anomaly was found on the (b)(4) devices manufactured with the same lot #.Device analysis: the instrument was returned to limacorporate for further analysis.According to the surgical technique, removal of the humeral body shall be performed using the smr expansion extractor (product code: 9013.52.165) in combination with the universal stem for extractor (product code: 9013.50.175).The universal stem is inserted into the expansion extractor, allowing the extractor tines to expand inside the humeral body.When used together with the multipurpose handle and the t-handle with zimmer connection, this configuration enables disengagement of the humeral body from the humeral stem.In the reported event, the instrument was used for removal of a humeral adaptor during surgery; however, no information was provided regarding the other components assembled with the instrument during the procedure.Visual inspection of the returned device revealed plastically deformed tines, one of which was fractured.The observed damage is consistent with repeated mechanical overloading at the distal end of the instrument.According to the r&d and quality departments assessment, the deformation pattern suggests that during the procedure the tines likely bottomed out against the component and the surgeon continued to tighten or advance the instrument.This resulted in excessive force being applied to the tines, leading to bending and subsequent breakage.Further investigation of the incident was not possible.However, considering that: review of the manufacturing records identified no anomalies for instruments manufactured under lot no.15aa052; the instrument was manufactured in 2015 and has been in clinical use for approximately 10 years; the observed deformation of the tines suggests improper use of the instrument; no additional investigation could be performed due to the lack of information regarding the components used in combination with the instrument during surgery.It can be concluded that the event was not product-related.Pms data: this is the second event in the past 3 years from (b)(4) instruments supplied in australia up to date ((b)(4)).3 similar events in the past 3 years from (b)(4) instruments supplied worldwide up to date ((b)(4)).Please note that this occurrence rate is overestimated because it does not consider the reuse of the instruments but only the total number of pieces supplied to the market.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions are required for this specific case.Limacorporate continues monitoring the market to promptly detect any further similar issue.Please note this is a final mdr report.
Event or Problem Description
During shoulder surgery performed on (b)(6) 2025, when using the smr - expansion extractor (product code 9013.52.165, lot #15aa052).When using the instrument for the humeral adaptor, the pegs were not straight.It ended up breaking off at the end.Surgical time extended by 20 minutes.The surgical time was extended by 20 minutes due to the issue.Event happened in australia.

• Brand Name: SMR SHOULDER
• Common Device Name: EXPANSION EXTRACTOR
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 23365752
• Report Number: 3008021110-2025-00145
• Device Sequence Number: 21319645
• Product Code: KWT
• UDI-Device Identifier: 08033390097598
• UDI-Public: 08033390097598
• 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,Followup
• Report Date (Section B): 10/23/2025

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: EXPANSION EXTRACTOR
• Device Catalogue Number: 9013.52.165
• 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: 10/23/2025
• Supplement Report FDA Received Date: 02/18/2026
• 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: Required Intervention
• Patient Sex: Unknown