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

Model Number	9013.02.301
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a revision surgery performed on (b)(6)2025, due to low grad infection, an intraoperative issue occurred.When explanting the stem, the thread of smr - stem extractor (product code: 9013.02.301 - lot: 15aa269a) broke.The stem remained in the humeral bone.The operator had to saw the bone to explant the humeral stem (product code:1304.15.190 - lot: 2400630).Then the bone was fixed with cerclages.The surgery was prolonged about 25 minutes.For the revision surgery procedure complaint number (b)(4) (mdr report number 3008021110-2025-00128) was created and will be submitted separately.Event occurred in germany.
Additional Manufacturer Narrative
Checking the device history records on the involved lot number 15aa269a no pre-existing anomalies were highlighted.A final report will be submitted after the investigation is completed.
Additional Manufacturer Narrative
Checking the device history records on the involved lot number 15aa269a no pre-existing anomalies were highlighted.The instruments were available to be returned for inspection to limacorporate.Given the position of the instrument's breakage (in the threaded section), it is considered likely that the instrument was not fully screwed to the end, and that proper contact between the instrument surface and the stem surface was not achieved.Furthermore, the lot in question was manufactured in 2015.Although the exact number of uses is unknown, it is reasonable to assume that the instrument has undergone multiple uses, considering it has been on the market for nearly ten years.Notably, this lot is among the first five produced and released, compared with approximately fifty smr - stem extractor lots currently available.The subsidiary also confirmed that the specified functional tests on this instrument are properly carried out.Considering that: - no pre-existing anomaly was discovered by checking the dhrs of the instrument involved in the event - the findings of the internal investigation suggesting improper assembly during use, we can conclude that the event is not product-related, but rather to use-related factors.Pms data: according to our pms data, we can estimate the breakage rate of the instrument stem extractor (code: 9013.02.301) to be (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 manufactured.This is an mdr final report.
Event or Problem Description
During a revision surgery performed on (b)(6) 2025, due to low grad infection, an intraoperative issue occurred.When explanting the stem, the thread of smr - stem extractor (product code: 9013.02.301 - lot: 15aa269a) broke.The stem remained in the humeral bone.The operator had to saw the bone to explant the humeral stem (product code: 1304.15.190 - lot: 2400630).Then the bone was fixed with cerclages.The surgery was prolonged about 25 minutes.For the revision surgery procedure complaitn number (b)(4) (mdr report number 3008021110-2025-00128) was created and will be submitted separately.Event occurred in germany.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: STEM EXTRACTOR
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 23096027
• Report Number: 3008021110-2025-00127
• Device Sequence Number: 15644793
• Product Code: HWB
• UDI-Device Identifier: 08033390097987
• UDI-Public: 08033390097987
• Combination Product (Y/N): N
• 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): 01/29/2026

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: 9013.02.301
• Device Catalogue Number: 9013.02.301
• Device Lot Number: 15AA269A
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 01/30/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown