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

Model Number	STEM IMPACTOR
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint source reported that during normal insertion of the trial stems in sequence, when trail stem 16 short was inserted and impacted, the black tip at the end of the smr - stem impactor (product code: 9013.02.302, lot nr.15aa096b) broke and was stuck in the trial stem.The surgeon was able to remove the stuck trial stem from humeral canal by himself.It was not possible to use adaptor 9095.11.M51 because of the stuck black tip.The broken tip was removed with a bit of force.The surgery was prolonged for 4 minutes.The complaint source tested the trial 16 stem with another impactor, and it functioned fine.The event occurred in germany.
Additional Manufacturer Narrative
The check of the device history records of involved lot number 15aa096b), confirmed the absence of pre-existing anomalies on the components manufactured with this lot number.We will submit a final report after the conclusion of the investigation.
Event or Problem Description
The complaint source reported that during normal insertion of the trial stems in sequence, when trail stem 16 short was inserted and impacted, the black tip at the end of the smr - stem impactor (product code: 9013.02.302, lot nr.15aa096b) broke and was stuck in the trial stem.The surgeon was able to remove the stuck trial stem from humeral canal by himself.It was not possible to use adaptor 9095.11.M51 because of the stuck black tip.The broken tip was removed with a bit of force.The surgery was prolonged for 4 minutes.The complaint source tested the trial 16 stem with another impactor, and it functioned fine.The event occurred in germany.
Additional Manufacturer Narrative
The check of the device history records of involved lot number: 15aa096b, confirmed the absence of pre-existing anomalies on the components manufactured with this lot number.This is the first and only complaint received on the lot number: 15aa096b involved.The involved instrument was sent to limacorporate for further investigation.From a visual examination the reported issue, breakage of the black tip at the end of the smr - stem impactor, was confirmed.We cannot determine with certainty the cause of the reported breakage, however, considering the absence of pre-existing anomalies by the check of the dhrs and the visual inspection on the returned instrument, we believe that it got broken probably due to wear related to repeated and maybe inaccurate uses of instrument over time.Complaint not product related.Pms data: according to our pms data the occurrence rate of intra-operatively breakage of the tip of smr - stem impactor (product code: 9013.02.302) is around (b)(4).Based on the root cause analysis performed and according to the relevant pms data, no corrective actions are required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.This is a final mdr report.

• Brand Name: SMR SHOULDER
• Common Device Name: STEM IMPACTOR
• 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; villanova di san daniele, udine, ita
• MDR Report Key: 20448951
• Report Number: 3008021110-2024-00089
• Device Sequence Number: 7110194
• Product Code: HSD
• UDI-Device Identifier: 08033390098342
• UDI-Public: 08033390098342
• 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): 02/04/2025

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: STEM IMPACTOR
• Device Catalogue Number: 9013.02.302
• Device Lot Number: 15AA096B
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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