MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR DIA. 14MM - TRIAL STEM WITH QUICK CONNECTION; KWT, HSD

Model Number 9013.02.141

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Code Available (3191)

Event Date 03/09/2016

Event Type  malfunction  

Manufacturer Narrative

The check of the dhr of the lot # involved (2014aa623) did not show any anomaly on the 61 smr trial stems (model # 9013.02.141) manufactured with these lot #.No other complaint was received on this lot #.We received the trial stem and guide for conical reamer involved in the intra-op issue.By a visual analysis, the 2 pins of the trial stem taper protrude externally, while these pins are intended to protrude internally on the trial stem to engage the conical guide; because of the anomalous position of the 2 pins, it was impossible to obtain a stable coupling between trial stem and conical guide intra-op.No anomaly detected on the guide for conical reamer.Pictures of the trial stem obtained through microscope show that the pins are shifted externally due to failure of the welding.We don't know when exactly this failure of welding occurred; the trial stem involved was manufactured in january 2015, so it's likely that it was used with the pins in the correct position a certain amount of times before failure of the welding.(b)(4).No corrective actions have been planned for this specific event.Lima corporate will continue monitoring the market.

Event Description

During a smr shoulder surgery, the guide for conical reamer and the trial stem would not stay tightened together, due to the trial stem pins being out of place.Because of this, it was difficult for surgeon to ream the humeral bone properly.Surgery time prolonged of 30-45 minutes; no other consequences for the patient.Event occurred in the us on the (b)(6) 2016.

• Brand Name: SMR DIA. 14MM - TRIAL STEM WITH QUICK CONNECTION
• Type of Device: KWT, HSD
• Manufacturer (Section D): LIMACORPORATE S.P.A.; IT
• Manufacturer (Section G): LIMACORPORATE S.P.A.; IT
• Manufacturer Contact: giulio puppa ; IT
• MDR Report Key: 5630491
• MDR Text Key: 45205879
• Report Number: 3008021110-2016-00020
• 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
• Reporter Occupation: Other
• Type of Report: Initial

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 Operator: Health Professional
• Device Model Number: 9013.02.141
• Device Lot Number: 2014AA623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2015
• 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): Hospitalization