MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR 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 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

We will submit a final report once the investigation will be completed.

Event Description

During surgery, 1 out of 3 pins of the smr prosthesis introducer code 9013.02.320, lot# 200803713 broke off.Thanks to the intra operative x-rays taken, it was possible to find and easily remove the pin initially fallen inside the patient, so no consequences were reported.Prolonged surgery time of about 5 mins.Event happened in (b)(6).

Manufacturer Narrative

No anomalies detected by checking the manufacturing charts of the device involved (lot# 200803713).We received the broken instrument 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.It's likely that 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 cana); in fact, 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 march 2009, we believe that the breakage of the pin happened after a high number of uses of the instrument.We also received the broken introducer, and we repeated the measure of the hardness on its surface (a hardness of 45 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 44 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.Before becoming aware of this event, and precisely in 2013, (b)(4) 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.The instrument involved in this case was available on the market since march 2009, therefore it was manufactured before the improvement described above.No breakages of the improved instrument have been reported until now.Our analysis on similar complaints showed that the instruments involved were compliant to specifications.These events are very unlikely to occur if there is a proper connection between the devices (introducer and anatomic humeral body) before impaction, and if the impaction is performed properly.To further reduce the already low risk of breakage of the pins, the improved introducers (manufactured since 2013) are gradually and completely replacing the previous version instruments on the worldwide market.

Event Description

During surgery, 1 out of 3 pins of the smr prosthesis introducer model# 9013.02.320, lot# 200803713 broke off.Thanks to the intra operative x-rays taken, it was possible to find and easily remove the pin initially fallen inside the patient, so no consequences were reported.Prolonged surgery time of about 5 mins to remove the broken pin from patient.Event occurred in (b)(6).

• Brand Name: SMR PROSTHESIS INTRODUCER
• Type of Device: SMR 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, udine 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038 ; 2 945511
• MDR Report Key: 6371421
• MDR Text Key: 69266270
• Report Number: 3008021110-2017-00013
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• 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: 200803713
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2009
• 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