MAUDE Adverse Event Report: LIMACORPORATE SPA SMR - GLENOID IMPACTOR; SMR - GLENOID IMPACTOR (KWT, HSD)

Model Number 9013.75.110

Device Problems Device Alarm System (1012); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot #1408485, no anomaly was found on a total of 29 glenoid impactors manufactured with this lot.This is the first and only complaint received on this lot #.We will submit a final mdr once the investigation will be completed.

Event Description

Intra-operative issue occurred during smr surgery on the (b)(6) 2019.Surgeon was trying to remove the metal back (not marked in usa) when the impactor code 9013.75.110, lot #1408485 got stuck into it.The issue prolonged the surgery of 1 hour because it took time to remove the implant from the glenoid.Finally, another implant of the same size was implanted using the liner impactor.Event occurred in (b)(6).

• Brand Name: SMR - GLENOID IMPACTOR
• Type of Device: SMR - GLENOID IMPACTOR (KWT, HSD)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: federica malvaso ; via nazionale 52; villanova di san daniele; udine 33038 ; IT 33038
• MDR Report Key: 8975017
• MDR Text Key: 218739027
• Report Number: 3008021110-2019-00099
• 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
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9013.75.110
• Device Lot Number: 1408485
• Date Manufacturer Received: 09/02/2019
• 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