MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR - TRIAL STEM D.16 MM; DIA. 16 - TRIAL STEM WITH QUICK CONNECTION

Model Number 9013.02.161

Device Problems Material Puncture/Hole (1504); Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot #14aa473, no pre-existing anomalies were detected on the pieces manufactured with this lot #.We will submit a final mdr once the investigation will be completed.

Event Description

During primary shoulder surgery performed on (b)(6) 2021, difficulty was experienced in engaging the trial humeral body with the smr - trial stem d.16 mm (product code 9013.02.161, lot# 14aa473).The instruments were then managed to be engaged together.It was reported that at the end of the surgery, a hole was observed on the trial stem where a weld nibb should be.According to the complaint source, surgery was completed successfully with implantation of the humeral components.Surgery was prolonged of 4 minutes.Event happened in (b)(6).

Manufacturer Narrative

By checking the dhr of the lot #14aa473, no pre-existing anomalies were detected on the instruments manufactured with this lot #, thus indicating that the pieces released on the market were manufactured up to specifications.The instrument was not available to be returned to limacorporate for further analysis, therefore it was not possible to investigate the root cause of the event.Internal analysis based on trial stems returned from the market and affected by similar issues (connection difficulties due to internal pin welding failure), revealed that the root cause of the event is mostly related to the manufacturing process of a specific supplier, which manufactured the lot of trial stems involved in this complaint.The involved supplier does not produce smr trial stems for limacorporate anymore.Limacorporate introduced on the market a new design of smr trial stems, with new coupling mechanism between the trial stems and the guide for conical reamer.In the new design, the pins are no more present on the trial stem, therefore there is no possibility that a similar issue occurs with the new design of trial stems.Pms data: according to limacorporate pms data, considering that the instrument is reusable, we can estimate an occurrence rate of similar intra-operative issues with trial to be (b)(4) (worldwide data since 2014).None of the complaints led to serious consequences on the patients.No corrective actions needed for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final report.

Event Description

During a primary shoulder surgery performed on (b)(6) 2021, difficulty was experienced in engaging the trial humeral body with the smr - trial stem dia.16mm (product code 9013.02.161, lot# 14aa473).According to the complaint source, the trial stem was missing one of the pins.The instruments were then managed to be engaged together.Surgery was completed successfully with implantation of the humeral components (16mm finned stem, finned reverse humeral body and short 44mm reverse liner).Instrument was used according to the surgical technique.Surgery was prolonged of 4 minutes.Event happened in australia.

• Brand Name: SMR - TRIAL STEM D.16 MM
• Type of Device: DIA. 16 - TRIAL STEM WITH QUICK CONNECTION
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 12679415
• MDR Text Key: 285064829
• Report Number: 3008021110-2021-00027
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

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: 9013.02.161
• Device Lot Number: 14AA473
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other