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

Model Number 9013.02.161

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot #14aa322, no pre-existing anomaly was detected on all the instruments manufactured with this lot #.We will submit a final mdr once the investigation will be completed.

Event Description

Intra-op issue experienced during shoulder surgery.Exact date not known.The quick lock attachments of the instrument smr - trial stem d.16 mm (product code 9013.02.161, lot# 14aa322) did not connect.It was reported that one of the two internal pins was missing and complaint source was unsure if this pin broke off or was just not there.No delay in surgery time nor consequences for the patient have been reported.Event happened in (b)(4).

Event Description

Intra-operative issue experienced during shoulder surgery.Exact date not known.The quick lock attachments of the instrument smr - trial stem d.16 mm (product code 9013.02.161, lot# 14aa322) did not connect.It was reported that one of the two internal pins was missing and complaint source was unsure if this pin broke off or was missing.According to the last information received, the pin was actually missing prior to the surgery, causing the impossibility to attach the introducer handle to the trial stem.The specific trial stem was therefore skipped in the sequential reaming phase, moving to the next size (17mm) and causing only a temporar delay in the procedure sequencing.No consquences for the patient were reported.Event happened in canada.

Manufacturer Narrative

By checking the device history records of the lot #14aa322, no pre-existing anomaly was detected on all the instruments manufactured with this lot #, thus indicating that the pieces released on the market were manufactured up to specifications.The specific instrument was not returned to limacorporate for analysis, therefore it was not possible to investigate the root cause of this event.However, internal analysis based on trial stems returned from the market and affected by similar issues (i.E.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 produced also the lot of trial stems involved in this specific complaint.This 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.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, and considering that these devices are reusable, the estimated occurrence rate of similar intra-operative issues with the smr trial stems is (b)(4) (worldwide data, starting from 2014).None of these intra-operative incidents caused serious consequences for the patients.No corrective actions needed for this specific case.Limacorporate will keep the market monitored to detect any further similar event.

• Brand Name: SMR - TRIAL STEM D.16 MM
• Type of Device: DIA. 16 - TRIAL STEM WITH QUICK CONNECTION
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 10611934
• MDR Text Key: 209639034
• Report Number: 3008021110-2020-00076
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9013.02.161
• Device Lot Number: 14AA322
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other