MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR - TRIAL STEM D.22 MM; DIA. 22 - TRIAL STEM WITH QUICK CONNECTION

Model Number 9013.02.221

Device Problems Loose or Intermittent Connection (1371); Difficult or Delayed Activation (2577)

Patient Problem No Code Available (3191)

Event Date 07/31/2015

Event Type  malfunction  

Manufacturer Narrative

No anomalies detected by checking the manufacturing chart of the lot # of trial stem involved.No other complaints registered on this lot #, on a total of 6 trial stems manufactured with the lot # involved.We will receive the instruments involved (trial stem together with thw conical reamer guide) and analyze them before submitting our final report.

Event Description

During a smr reverse procedure dated (b)(6) 2015, there were difficulties in engaging and disengaging the conical reamer guide and the trial stem.This happened because of a loose pin at the top of the trial stem; consequently, it was difficult for the surgeon to accurately ream the seating for the reverse body.Surgical time prolonged of 20 minutes.The event occurred in (b)(6).

Manufacturer Narrative

No anomalies detected by checking the manufacturing chart of the lot # of trial stem involved.No other complaints registered on this lot #, on a total of (b)(4) trial stems manufactured with the lot # involved.We received the trial stem involved in the intra-op issue.By a visual analysis, the one (1) of the two (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 pin, it was difficult to engage and disengage the conical guide to the trial stem.Pictures of the trial stem obtained through microscope show that one (1) of the two (2) pins is 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 april 2015, therefore it is likely that it was used with the pins in the correct position a certain amount of times before failure of the welding.A total 4 similar complaints were reported on smr trial stems (family 9013.02.141÷241), involving failure of the pins welding, on a total of (b)(4) trial stems manufactured with these product codes ((b)(4)).Four (4) different lot # are involved in these 4 cases, therefore no indication of "lot # issue".No corrective actions have been planned for this specific event.Lima corporate will continue monitoring the market.

Event Description

During a smr reverse procedure dated (b)(6) 2015, there were difficulties in engaging and disengaging the conical reamer guide and the trial stem.This happened because of a loose pin at the top of the trial stem; consequently, it was difficult for the surgeon to accurately ream the seating for the reverse body.Surgical time prolonged of 20 minutes.Event occurred in (b)(6).

• Brand Name: SMR - TRIAL STEM D.22 MM
• Type of Device: DIA. 22 - TRIAL STEM WITH QUICK CONNECTION
• 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, udine 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038 ; 2 945511
• MDR Report Key: 5156320
• MDR Text Key: 28912055
• Report Number: 3008021110-2015-00044
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.02.221
• Device Lot Number: 14AA633
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2015
• 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