MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMALL/STD/LARGE M-B GLENOID IMPACTOR; M-B GLENOID IMPACTOR, KWT HSD

Model Number 9013.75.110

Device Problems Sticking (1597); Failure to Disconnect (2541)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The check of the dhr for the lot # of the involved impactor (lot# 201408486) did not show any anomaly on the 20 pieces placed on the market with this lot #.This is the first and only complaint received on this lot # and on this specific code.We also checked the dhr for the lot # of the involved metal-back (lot #201516955).No anomaly emerged on the 54 pieces placed on the market with this lot # and no other complaints were received also on this lot #.We received and analyzed the involved impactor and metal back.A dimensional check was performed: this check did not show any anomalies, confirming that the devices involved were manufactured in compliance to the specific requirements before being placed on the market.We also performed a functional check of the instrument.According to the analysis, the elastic peg was not completely tightened to the beating position required for the correct coupling with the metal back.In this situation, the elastic pliers of the peg do not interact with the groove inside the metal back, but interact with the internal conical section.In this situation, after the first impact, the blocking of the metal back with the instrument may occur (event which caused the intra-operative issue).This event may happen only if the peg is not completely tightened in the correct position.The peg is removable in order to clean the instrument, but the peg must be completely tightened before engaging the metal back.According to our analysis, in this specific case the instrument was used in suboptimal conditions and this caused the intra-operative issue.From our pms data, this is the first and only complaint received on this instrument (code #9013.75.110).A total of (b)(4) impactors with this code have been manufactured since 2008.(b)(4).No corrective action planned for this specific case.Limacorporate will continue monitoring the market.

Event Description

Intra-operative issue involving a glenoid impactor (code #9013.75.110; lot #201408486).According to the received information, the metal back got stuck with the impactor and it was not possible to separate the devices.In order to complete the surgery, a new metal back was opened and impacted successfully on the glenoid bone.The event occurred in (b)(6).

• Brand Name: SMALL/STD/LARGE M-B GLENOID IMPACTOR
• Type of Device: M-B GLENOID IMPACTOR, KWT HSD
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038
• MDR Report Key: 6459718
• MDR Text Key: 72340101
• Report Number: 3008021110-2016-00085
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.75.110
• Device Lot Number: 201408486
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2014
• 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