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

Model Number	9013.52.165
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation checking the manufacturing charts, no pre-existing anomaly has been found out in the items belonging to the same lot number as the component involved in the event.The manufacturer will share the final mdr as soon as the investigation is complete.
Event or Problem Description
During a shoulder surgery on (b)(6) 2024, two out of the 4 prongs of the following instrument broke off: smr - expansion extractor (product code 9013.52.165, lot number 14aa253) the surgery was completed removing the entire stem connected to proximal body.The instrument has been used 5 times approximately.There was no extension of the surgical time.The patient is a male.Event happened in the united states.
Additional Manufacturer Narrative
Investigation checking the manufacturing charts, no pre-existing anomaly has been found out in the items belonging to the same lot number as the component involved in the event.The instrument involved in this event has been returned to the manufacturer, together with the stem and the body removed, for further investigation.As the instrument returned was broken, to replicate the surgical steps we retrieved a new instrument, belonging to the same product code.According to the surgical technique, the surgeon should insert the instrument expansion extractor in the humeral body.Afterward, the surgeon should insert the universal stem for extractor (code 9013.50.175) into the expansion extractor, threading the universal stem into the humeral body and stabilizing the expansion extractor.These steps were repeated by using the new instrument and the returned explanted components, and the test was completed without finding any malfunction.This led us to conclude that the most probable root causes of the problem occurred could be the misuse of the instrument or the wear on it (since the lot number of the complained component was manufactured in 2014).Hence, considering that: - no pre-existing anomaly was found by checking the manufacturing charts of the instrument involved in this event - a new instrument belonging to the same product code as the complained instrument was tested without finding any malfunction, leading to conclude that the causes of the event could be misuse or the wear of the instrument.We can confirm that the event is not product related.Pms data according to our pms data, we can estimate the breakage rate of the instrument expansion extractor to be 0.11% (ww).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 manufactured.Based on the root cause analysis performed and according to the relevant pms data, no corrective action is required for this specific case.The manufacturer will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.
Event or Problem Description
During a shoulder surgery on (b)(6) 2024, two out of the 4 prongs of the following instrument broke off: - smr - expansion extractor (product code 9013.52.165, lot number 14aa253) the surgery was completed removing the entire stem connected to proximal body.The instrument has been used 5 times approximately.There was no extension of the surgical time.The patient is a male, in its 70s.The event happened in the united states.

• 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
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 21091029
• Report Number: 3008021110-2024-00109
• Device Sequence Number: 8934993
• 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): 07/08/2025

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: 9013.52.165
• Device Lot Number: 14AA253
• 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: 01/07/2025
• Supplement Report FDA Received Date: 07/08/2025
• 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