MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR STEM EXTRACTOR

Model Number 9013.02.301

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Unspecified Infection (1930)

Event Type  malfunction  

Manufacturer Narrative

The check of the dhr of the lot # (stem extractor: lot #2015aa269; glenoid extractor: lot #2015aa137) involved in this intra-op issue did not show any pre-existing anomaly on the 20 stem extractors released on the market with lot #2015aa269 and on the 22 glenoid extractors manufactured with lot #2015aa137.This is the first and only complaint received on these lot#.We will submit a final mdr once we conclude our investigation on this case.

Event Description

Intra-op issue involving the smr stem extractor (code #9013.02.301; lot #2015aa269) and the smr extractor for glenoid (code #9013.02.310; lot #2015aa137).During a shoulder revision surgery due to infection, the surgeon was about to remove the metal back when the threaded tip of the stem extractor broke off inside the glenoid extractor.The metal back glenoid was extracted with a hammer with a hook.The surgical time was prolonged for less than a minute.No adverse effect for the patient was reported.Event occurred in united states.

• Brand Name: SMR STEM EXTRACTOR
• Type of Device: STEM EXTRACTOR
• 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: 6636253
• MDR Text Key: 77618751
• Report Number: 3008021110-2016-00090
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• PMA/PMN Number: CLASS I
• 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: 06/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.02.301
• Device Lot Number: 2015AA269
• Date Device Manufactured: 05/15/2015
• 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