MAUDE Adverse Event Report: LIMACORPORATE S.P.A. QUICK CONNECTION STEM IMPACTOR; KWT, HSD

Model Number 9013.02.302

Device Problems Device Inoperable (1663); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The check of the dhr related to the lot # involved (2014aa398) did not show any pre-existing anomaly on the (b)(4) instruments manufactured with this lot #.We did not receive the instrument involved so we could not analyze it.

Event Description

Stem trial inserter (model # 9013.02.302, lot # 2014aa398) was found to be unusable intra-op when unwrapped due to pin missing from upper fulcrum point of handle.No impact on patient.Additional info received on the event: "this issue was noticed before surgery when the rep was getting the case set up with the (b)(6).So, this did not add any time to the surgery and the surgeon never even knew this was an issue.They just opened a another tray to get another handle." the event occurred in the us.

• Brand Name: QUICK CONNECTION STEM IMPACTOR
• 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: 5479634
• MDR Text Key: 40032617
• Report Number: 3008021110-2015-00063
• 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

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: No Information
• Device Model Number: 9013.02.302
• Device Lot Number: 2014AA398
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2014
• 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