MAUDE Adverse Event Report: LIMACORPORATE SPA STEM EXTRACTOR

Model Number 9013.02.301

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

We will send a final report once the investigation will be concluded.

Event Description

During a shoulder revision surgery, smr stem extractor - code 9013.02.301, lot# 2015aa272 - was damaged.According to the info reported, more than one intra-operative issues were experienced during the revision surgery: procedure was to remove and replace tt mb baseplate and tt peg (reason of revision unknown); firstly, it was tried to remove and replace mb tt baseplate size standard with 2x different s/r tt baseplate extractors (code 9013.75.391, lot# 15aa006a and 15aa99wb).This inappropriate instrument's use lead to s/r tt baseplate extractor's damage.An appropriate (std) baseplate extractor was at the end used and mb tt baseplate was successfully dissociated from tt peg; upon tt peg removal, the cannulated reamer trephines (code 9013.75.396, lot# 15aa9a4 and 15aa027a) were damaged while attempting to ream over peg.Surgeon had issues attempting to thread in reamer guide.Secondary option for peg removal was to thread in mb extractor with slap handle / stem extractor: at this point, stem extractor tip sheared off.Peg was eventually removed successfully.Luckily, other instruments were available to assist in completing successfully the surgery.Only few minutes of prolonged surgery time reported.No consequences for the patient.Event happened in us.

• Brand Name: STEM EXTRACTOR
• Type of Device: STEM EXTRACTOR
• Manufacturer (Section D): LIMACORPORATE SPA
• MDR Report Key: 7697552
• MDR Text Key: 114713405
• Report Number: 3008021110-2018-00053
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

• 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: 2015AA272
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: No
• 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