MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR PROSTHESIS INTRODUCER; KWT, HSD

Model Number 9013.02.320

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 09/24/2014

Event Type  malfunction  

Event Description

One of the 3 lugs of the smr prosthesis introducer broke off whilst being used to impact the implant (coupled humeral stem + humeral body) into the humeral canal.It did not affect the procedure as the introducer had still 2 lugs attached out of the 3, so the surgeon could use the introducer with no issues.The event occurred in (b)(6).

Manufacturer Narrative

We checked the dhr of the batch involved, without finding any anomaly in the dimensions and the raw material certificate (b)(6) of the instruments.A total of (b)(4) introducers have been manufactured with the lot # 201106631, and we received no other signalings on this lot #.We will receive the broken instrument and analyze it, then we will submit a follow-up emdr on this intra-operative breakage.There are no consequences for patient health due to these intra-operative breakages.However, before becoming aware of this event, in 2013 lima corporate 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 lugs, thus obtaining a reduction in the cantilever part.This adjustment increases the mechanical strength of the lugs, and prolongs the service life of the introducers.The instrument involved in this case was manufactured in 2011, before the improvement described above.Device not yet returned.

Manufacturer Narrative

We checked the dhr of the batch involved, without finding any anomaly in the dimensions and the raw material certificate (aisi 630 h900 heat treated) of the instruments.A total of 26 introducers have been manufactured with the lot # 201106631, and we received no other signalings on this lot number.We don't know how many times the introducer was used; as it was manufactured in 2011, we may suppose that the breakage of the lug happened after a certain number of uses of the instrument.We also received the broken introducer, and we repeated the measure of the hardness on its surface near to the broken lug (a hardness of 47 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 45 hrc, which is fully compliant with those recommended by the astm a564 (minimum allowed 40 hrc) for the aisi 630 h900 heat treated.Summarizing, no pre-existing defects on the introducer were detected.We believe that the intra-op issue may have been caused by an unexpected stress applied at the base of the lugs during the impaction of the smr prosthesis into the humeral canal.There are no consequences for patient health due to these intra-operative breakages.However, before becoming aware of this event, 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 lugs, thus obtaining a reduction in the cantilever part.This adjustment increases the mechanical strength of the lugs, and prolongs the service life of the introducers.The instrument involved in this case was manufactured in 2011, before the improvement described above.No breakages of the improved instrument have been reported until now.The improved instruments will gradually and completely replace the previous version on the market.

Event Description

One of the 3 lugs of the smr prosthesis introducer broke off whilst being used to impact the implant (coupled humeral stem + humeral body) into the humeral canal.It did not affect the procedure as the introducer had still 2 lugs attached out of the 3, so the surgeon could use the introducer with no issues.The event occurred in (b)(6).

• Brand Name: SMR PROSTHESIS INTRODUCER
• Type of Device: KWT, HSD
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; san daniele del friuli, udine 3303 8; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via nazionale 52; san daniele del friuli, udine 3303 8; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale 52; san daniele del friuli, udine 33038 ; IT 33038
• MDR Report Key: 4278609
• MDR Text Key: 5226493
• Report Number: 3008021110-2014-00022
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 10/30/2014

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: 201106631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 11/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2011
• 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