MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR STEM IMPACTOR

Model Number 9013.02.302

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

No anomalies by checking the manufacturing charts of the lot # of instrument involved.No other similar complaints registered on this lot #, on a total of 48 instruments manufactured with these lot #.We will receive the instrument involved and analyze it before submitting our final report.

Event Description

Intra-op issue occurred during a total shoulder replacement surgery dated (b)(6) 2016.The pin felt from the smr stem impactor upon trial stem removal.The pin was removed and there was no consequence for the patient.Surgery time extended of 30 minutes.Event occurred in (b)(6).

Manufacturer Narrative

No anomalies by checking the dhr of the lot # of instrument involved ((b)(4)).No other similar complaints registered on this lot #, on a total of (b)(4) instruments manufactured with these lot #.Despite of the initial info provided, we did not receive the instrument involved so we could not analyze it.An analysis on another similar issue occurred in (b)(6) on a similar instrument with model # 9013.02.303 (lima complaint # (b)(4), mfr report # 3008021110-2015-00023) showed that the likely cause of the pin loosening was a slight dimensional anomaly on the pin and on the corresponding hole of the impactor (i.E.Slight under-dimensioning of the pin diameter and slight over-dimensioning of the hole diameter).In february 2015, before becoming aware of this type of complaint, a slight adjustment (a reduction) in the tolerances of the pin holes in the impactor body was made which reduces the risk of occurrence of similar issues.This adjustment was made for both the impactors 9013.02.302-9013.02.303.Excluding the 2 above mentioned cases (both instruments manufactured before the adjustment mentioned above), no other similar intra-op issues have been received on instrument part number 9013.02.302-9013.02.303.Lima corporate will continue to monitor complaints on these products.

Event Description

Intra-op issue occurred during a total shoulder replacement surgery dated (b)(6) 2016.The pin felt from the smr stem impactor upon trial stem removal.The pin was removed and there was no consequence for the patient.Surgery time extended of 30 minutes.Event occurred in (b)(6).

• Brand Name: SMR STEM IMPACTOR
• Type of Device: SMR STEM IMPACTOR
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, italy (udine) 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, italy (udine) 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 5462764
• MDR Text Key: 39488719
• Report Number: 3008021110-2016-00006
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.02.302
• Device Lot Number: 2014AA149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2014
• 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