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

Model Number 9013.52.147

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/02/2022

Event Type  malfunction  

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #19ag0y5, no pre-existing anomaly was found on the components manufactured with the same lot #.We submit a final mdr as soon as the investigation is completed.

Event Description

During a primary shoulder surgery performed on (b)(6) 2022, the reverse adaptor sleeve (product code 9013.52.147, lot #19ag0y5) failed to grip trial instruments.It was then noticed that tip was broken.It was reported that a definitive implant impactor was used to finish the case.Surgery was prolonged by 5 minutes.According to the received information the instrument was used as per surgical technique.The estimated number of uses of the instrument is 40.Patient is a male, 69 years old.Event happened in new zealand.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #19ag0y5, no pre-existing anomaly was found on the components manufactured with the same lot #.Instrument analysis: the instrument was returned to limacorporate for further analysis.The visual inspection confirmed that the plier of the instrument has broken, however the tip of the plier not available to be returned to limacorporate.Considering that: check of the manufacturing charts highlighted no anomalies on the instruments manufactured with lot #19ag0y5; the visual analysis confirmed that the plier of the instrument broke off and for this reason it could not engage to the trial instruments; we cannot define with certainty the root cause of the event.It was reported that the breakage might have occurred during the previous surgery in which the instrument was used, thus we can just hypothesize that unexpected stresses have been applied, 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).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 performed on (b)(6) 2022, it was reported that before proceeding to reaming the proximal humerus, the reverse adaptor sleeve (product code 9013.52.147, lot #19ag0y5) failed to grip trial instruments (trial stem and conical reamer guide).It was then noticed that its tip was broken.According to the received information, the breakage might have occurred during the previous surgery in which the instrument was used.No further information is available on it.It was reported that a definitive implant impactor was used to finish the case.The surgeon was satisfied with the final implant.Surgery was prolonged by 5 minutes.According to the received information the instrument was used as per surgical technique.The estimated number of uses of the instrument is 40.Patient is a male, 69 years old.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: 15649291
• MDR Text Key: 307006538
• Report Number: 3008021110-2022-00094
• 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

• 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: 19AG0Y5
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2023
• 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