MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SYSTEM; SMR SYSTEM - FINNED STEM DIA. 17 MM L. 80 MM

Model Number	1304.15.170
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The check of the manufacturing charts of the lot# of the smr cementless finned stem involved (201520757) did not show any packaging anomaly on the 35 smr cementless finned stems manufactured with this lot #.No other complaints reported on this lot#.We will send a final report once the investigation will be completed.
Event or Problem Description
Packaging issue involving a smr cementless finned stem, model# 1304.15.170, lot# 1520757.When opening the package containing the stem, some scratches have been noticed on the inner pouch and also white powder was observed on the surface of the stem.According to the info reported, the powder was completely removed by the nurse using sterile water and, after this step, the stem was implanted.No health damage for the patient reported.Event happened in (b)(6).
Event or Problem Description
Packaging issue involving a smr cementless finned stem, model# 1304.15.170, lot# 1520757.When opening the package containing the stem, some scratches have been noticed on the inner pouch and also white powder was observed on the surface of the stem.According to the info reported, the powder was completely removed by the nurse using sterile water and, after this step, the stem was implanted.No health damage for the patient was reported.Event happened in japan.
Additional Manufacturer Narrative
Checking the manufacturing charts of the lot #1520757 involved in the complaint, no packaging nor manufacturing anomaly was found on the 35 smr cementless finned stems manufactured with that lot #.This is the first and only complaint received on that lot #.Device analysis the device was implanted, its packaging discarded, and no picture was available for analysis.According to the received information, there was some powder on the device that was removed by the nurse.It is hypothesized that the power comes from the rubbing of the device surface on the plastic pouch.Based on the received information, we cannot further analyze the incident.We can hypothesize that the reported damages have been caused during the transport.Still, the inner pouch solely was affected by the damages, therefore the sterility of the device was not compromised: indeed, the device was implanted.Considering that: · check of manufacturing charts highlighted no anomalies on the lot #1520757; · no picture or part of the packaging was received for investigation; we cannot define with certainty a root cause for the event.Still, we can state that the event is not product related, hypothesizing that the reported damages have been caused during the transport.The packaging had then been improved to avoid the folding of the pouches inside the cardboard boxes.Moreover, the outer packaging (i.E.The carboard boxes) is bigger in size and features sponges on the top and on the bottom of the box to further protect the device during transport.Pms data according to limacorporate pms data, the occurrence rate of packaging issues involving cementless humeral stems - belonging to the product codes 1304.15.Xxx - is <0.01%.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.Note: this is a final mdr.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR SYSTEM - FINNED STEM DIA. 17 MM L. 80 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; IT
• MDR Report Key: 6536428
• Report Number: 3008021110-2017-00033
• Device Sequence Number: 18856297
• Product Code: HSD
• UDI-Device Identifier: 08033390270809
• UDI-Public: 08033390270809
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101263
• 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): 06/26/2025

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
• Operator of Device: Health Professional
• Device Model Number: 1304.15.170
• Device Catalogue Number: 1304.15.170
• Device Lot Number: 1520757
• Was Device Available for Evaluation?: No
• 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: 05/02/2017
• Supplement Report FDA Received Date: 07/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown