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

Model Number 9013.52.147

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot #19ag03e, no pre-existing anomalies were detected on the pieces manufactured with this lot #.This is the first and only complaint received on this lot#.We will submit a final mdr once the investigation will be completed.

Event Description

During primary shoulder surgery taking place on (b)(6) 2021, the reverse adaptor sleeve (product code 9013.52.147, lot# 19ag03e) was found having the metal tip break off.According to the complaint source, surgeon was attempting to implant trial stem and conical reamer guide, when found that the reverse adaptor sleeve did not hold the trial stem/conical reamer guide.It was reported that the tip may had probably broken off during a previous case.Another instrument was used to complete the surgery.According to the provided information, the instrument was used as per surgical technique.Surgery was prolonged of 5 minutes.Event happened in (b)(6).

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #19ag03e, no pre-existing anomaly was found on the instruments manufactured with the same lot #.This is the first and only complaint received on this lot #.Instrument analysis: the instrument was returned to limacorporate for further analysis.The visual inspection confirmed that the tip of the instrument has broken (visual inspection done on the pictures provided by the complaint source.Tip not available to be returned to limacorporate).The tip was part of the plier that ensures the engagement of the sleeve to other instruments.A dimensional analysis was performed on the broken plier.The analysis confirmed no dimensional anomalies on the plier.Considering that: check of the manufacturing charts highlighted no anomalies on the instruments manufactured with lot #19ag03e; the visual analysis confirmed that the plier of the instrument broke and for this reason it could not engage to the trial stem; the dimensional analysis confirmed no dimensional anomalies detected on the retrieved plier.We cannot define with certainty the root cause of the event.We can just hypothesize that unexpected stresses have been applied during surgery, leading to plier's breakage.Pms data: (b)(4).The device involved in the complaint is in version 00.Before becoming aware of this event, limacorporate has increased the thickness of the instrument's plier as an improvement to further enhance its mechanical strength, and thus released the new version of the instrument (v.01).Instruments in version 01 are available on the market since december 2020.(b)(4).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.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions are required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

Event Description

During a primary shoulder surgery taking place on (b)(6) 2021, the reverse adaptor sleeve (product code 9013.52.147, lot #19ag03e) was found having the metal tip broken off.According to the complaint source, surgeon was attempting to implant the trial stem and the conical reamer guide, when he found that the reverse adaptor sleeve did not hold the trial stem/conical reamer guide.It was reported that the tip may had probably broken off during a previous case.Another instrument was used to complete the surgery.According to the provided information, the instrument was used as per surgical technique.Surgery was prolonged of 5 minutes.Event happened in new zealand.

• Brand Name: 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: 11676658
• MDR Text Key: 247947227
• Report Number: 3008021110-2021-00030
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9013.52.147
• Device Catalogue Number: 9013.52.147
• Device Lot Number: 19AG03E
• Is the Reporter a Health Professional?: No
• 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): Other