MAUDE Adverse Event Report: LIMACORPORATE SPA SMR - STEM EXTRACTOR

Model Number 9013.02.301

Device Problem Break (1069)

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

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot#15aa030, no pre-existing anomaly was detected.This is the first and only complaint received on this lot#.We will submit a final mdr once the investigation will be concluded.

Event Description

Intra-operative issue occurred during shoulder revision surgery performed on (b)(6) 2020.According to the information reported, during surgery 2 smr - stem extractors (product code 9013.02.301 - lot #15aa030) broke and the threads remained into the stem, but surgeon was able to remove them.Complaint source reported that the reason was that the patient head was in the way of the platform on the stem extractor and in both cases, surgeon did not threaded the extractor to the end.Finally, surgeon used a 3rd stem extractor, threaded it to the end and used a flexible osteotome to successfully extract the stem.The event prolonged the surgery of 25-30 minutes.

• Brand Name: SMR - STEM EXTRACTOR
• Type of Device: SMR - STEM EXTRACTOR
• 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: 10166950
• MDR Text Key: 199898207
• Report Number: 3008021110-2020-00044
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 06/18/2020

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: 9013.02.301
• Device Catalogue Number: 9013.02.301
• Device Lot Number: 15AA030
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 06/18/2020
• 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