MAUDE Adverse Event Report: LIMACORPORATE S.P.A. GLENOSPHERE IMPACTOR-EXTRACTOR; KWS

Model Number 9013.74.141

Device Problems Break (1069); Entrapment of Device (1212)

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

Event Date 08/26/2015

Event Type  malfunction  

Manufacturer Narrative

Check of dhr of the lot # of instrument involved (2015aa094) provided by the supplier of the instrument (orchid arab) did not show any anomaly on the 36 pieces released on the market with this lot #.No other breakages reported on such instrument (model # 9013.74.141).We received the broken impactor-extractor and we verified that it broke approx 2mm above the base of the threaded section, which is to be screwed into the glenosphere to impact it into the metal back glenoid.As the breakage did not occur exactly at the base of the thread but 2mm above, we believe that the instrument could have been not completely tightened into the glenosphere causing the onset of unexpected multi-axial forces on the threaded section during the impaction; this could have significantly contributed to the breakage.In addition, we measured the hardness near to the broken thread of the extractor; an average value of 40 hrc has been measured.The values detected comply with those recommended by the astm a564 for the aisi 630 h900 heat treated, which is the material of the instrument.This is the 1st breakage reported of an instrument with model # 9013.74.141,(b)(4).No corrective actions have been planned.Limacorporate will keep monitored the market.

Event Description

Intra-op breakage of the threaded tip of the glenosphere impactor (model # 9013.74.141) when impacting the glenosphere.The threaded tip of the instrument was stuck in glenosphere and had to be dug out.The event occurred in the us.

• Brand Name: GLENOSPHERE IMPACTOR-EXTRACTOR
• Type of Device: KWS
• Manufacturer (Section D): LIMACORPORATE S.P.A.; IT
• Manufacturer (Section G): LIMACORPORATE S.P.A.; IT
• Manufacturer Contact: giulio puppa ; IT
• MDR Report Key: 5115843
• MDR Text Key: 27591650
• Report Number: 3008021110-2015-00039
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K110598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.74.141
• Device Lot Number: 2015AA094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2015
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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
• Patient Outcome(s): Hospitalization