MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PROSTHESIS INTRODUCER

Model Number 9013.02.320

Device Problems Break (1069); Component Falling (1105)

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

Event Date 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

The check of the dhr of the involved instrument (lot #200702798) did not show any anomaly on the (b)(4) pieces manufactured with this lot#.This is the first and only similar complaint reported for this lot#.We will submit a final emdr when the investigation will be completed.

Event Description

During shoulder arthroplasty, 1 of the 3 pins of the prosthesis introducer (model #9013.02.320; lot #200702798) broke off after impaction and fell in the patient.According to the reported information, there were no consequences for the patient and no significant increase of surgery time.Event happened in (b)(6).

Manufacturer Narrative

The check of the dhr of the involved instrument (lot #200702798) did not show any anomaly on the 22 pieces manufactured with this lot#.This is the first and only similar complaint reported for this lot#.We received the instrument with the broken pin and analyzed it.The breakage involved one of the 3 pins used to engage the anatomic humeral body on the instrument, in order to introduce the pre-assembled humeral stem + anatomic humeral body in the humeral canal.The breakage of the pin occurred during impaction of the pre-assembled humeral stem + anatomic humeral body into humeral canal (after their introduction into humeral canal); the impaction is the phase when the higher stresses are transmitted to the pins of the introducer.We don't know how many times the introducer was used; as it was available on the market since february 2007, we believe that the breakage of the pin happened after a high number of uses of the instrument.On the broken instrument returned, we repeated the measure of the hardness on its surface (a hardness of 44 hrc had been detected on the instrument before placing it on the market).The further hardness test performed on the broken instrument gave a value of 43 hrc, which is fully compliant with those recommended by the astm a564 (minimum allowed 40 hrc) for the aisi 630 h900 heat treated, which is the material of the introducer.Summarizing, no pre-existing defects on the introducer were detected.We believe that the intra-op issue may have been caused by unexpected stresses applied at the base of the lugs during the impaction of the smr prosthesis into the humeral canal, maybe combined with an incomplete (suboptimal) connection between introduced and anatomic humeral body before impaction.No corrective actions for this specific case.Before becoming aware of this event, and precisely in 2013, limacorporate slightly modified the geometry of the connection surface of the instrument with the humeral body.Basically, the improvement consists in adding material at the base of the pins of the introducer, thus obtaining a reduction in the cantilever part.This adjustment increases the mechanical strength of the pins, and prolongs the service life of the introducers.No breakages of the pins reported on the improved version of the instrument which, according to our traceability records, is the only one available in the us market.

Event Description

During a shoulder arthroplasty, 1 of the 3 pins of the prosthesis introducer (model #9013.02.320; lot #200702798) broke off after impaction and fell in the patient.According to the reported information, there were no consequences for the patient and no significant increase of surgery time.Event happened in (b)(6).

• Brand Name: PROSTHESIS INTRODUCER
• Type of Device: PROSTHESIS INTRODUCER
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer (Section G): 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: 6770050
• MDR Text Key: 83167360
• Report Number: 3008021110-2016-00133
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/07/2017

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: 9013.02.320
• Device Lot Number: 200702798
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 08/07/2017
• Supplement Dates Manufacturer Received: 12/02/2016
• Supplement Dates FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2007
• 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