MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR- REVERSE ADAPTOR SLEEVE

Model Number 9013.52.141

Device Problem Break (1069)

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

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

This is the first and only medical complaint received on this lot#.We will proceed with further investigation and submit a final mdr once concluded.

Event Description

Intra-operative issue occurred on the (b)(6) 2020: 9013.52.141: breakage of one prong of the reverse adaptor sleeve with code 9013.52.141, lot# 14aa221.According to the info received, the prong was visibly broken but didn't affect the surgery.Event happened in (b)(6).

Manufacturer Narrative

We checked the relevant dhr of the lot# involved and it was not possible to verify any anomaly affecting the lot involved.This is the first and only medical complaint received on this lot#.The instrument involved was not available to be returned to limacorporate for further analysis.We received a picture of the instrument: by a visual analysis, we could confirm that one of the 4 teeth of the instrument broke off at the base of the tooth.The remaining 3 teeth of the extractor were intact.According to the received information, the prong broke after reaming the proximal humerus for reverse tsr.Surgeon was able to remove the assembled trial stem and conical guide for reverse body.It was reported that the broken piece was not left in the patient.Furthermore, the broken prong was disposed of at the time of the surgery.Based on the very few info available and considering that no further investigation is possible on the instrument (unavailable), we can consider that: · the instrument had been manufactured in 2014 and the breakage occurred in (b)(6) 2020.Even if the number of uses is not known it must be considered that we are talking of a reusable tool; · previous analysis performed on a similar case allowed us to speculate that the prong's breakage could have been related to an intensive/unintended use of the instrument.No definitive conclusion can be drawn on the causes of the breakage of the instrument's prong but it is possible that the repeated use of the instrument may had caused slight and repeated bendings of the peg over time which eventually led to the breakage.Pms data: we are aware of a total of 3 cases of prong breakages of the specific instrument (product code 9013.52.141) according to our pms data, we can estimate the breakage rate of the instrument prong to be (b)(4) (ww).Please note that this occurrence rate is overestimated because it does not consider the reuse of the instruments but only the total number of pieces manufactured.As far as we are aware of, those breakages happened after several uses of the reverse adaptor sleeve.No specific corrective action for this case.Limacorporate will continue monitoring the market to promptly detect any future similar issue.Note: this is a final mdr.

Event Description

One prong of the smr reverse adaptor sleeve (product code 9013.52.141, lot# 14aa221) broke during a shoulder replacement surgery performed on (b)(6) 2020.According to the complaint source the issue did not affect the surgery that was successfully completed with no prolonged surgery time nor adverse outcome for the patient.Estimated number of uses of the instrument is unknown.Event happened in australia.

• Brand Name: SMR- REVERSE ADAPTOR SLEEVE
• Type of Device: REVERSE ADAPTOR SLEEVE
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 10096277
• MDR Text Key: 195713710
• Report Number: 3008021110-2020-00034
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9013.52.141
• Device Lot Number: 14AA221
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other