MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SCREWDRIVER SHAFT FOR AXLE; T15 SCREWDRIVER SHAFT WITH ZIMMER CONNECTION

Model Number 9015.90.006

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Joint Laxity (4526)

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

Checking the manufacturing and sterilization charts of the involved lot # 22bq06y, no preexisting anomaly was found on the device.Therefore, the product with this lot # has been properly sterilized before being placed on the market.Pms data.The event reported by complaint source is loosening of a customized humeral implant.No revision rate is to be provided since customized implants are manufactured as single pieces.Based on the root cause analysis performed and that this is a custom-made device, no corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issues.Note: this is a combined initial-final mdr.

Event Description

Description: on (b)(6) 2023 an elbow revision was performed due to a custom-made implant loosening of cmd 17-1277 humeral implant (product code 9617.99.043, lot number 1911366, sterilization number 1900254) discovered on (b)(6) 2022.Registered as mfr.3008021110-2022-00122, (lima ref.(b)(4) ) a new custom-made implant, (b)(6) was requested at that time.During the revision surgery ( (b)(6) 2023) the following was noted, "using the manufacturers instrumentation, the axle pin could not be disengaged from the components.The screw head was stripped.For this reason, the decision was made to proceed with removal of the modular ulnar body", "the ulnar body was disengaged from the ulnar stem and was checked and noted to be well fixed." a new ulnar body was attached to the existing ulnar stem with a screw.The component dislocated has been replaced and a humeral body was exchanged and implanted with the humeral stem from (b)(6), and "there were no complications noted".(b)(6) 2023 patient returned for post op check and is doing well.Components: previous surgery date - (b)(6) 2019.Patient - female.Date of birth - (b)(6) 1961.Explanted components screwdriver shaft for axle, commercial code 9015.90.006 - lot # 22bq06y - ster.# unknown.(b)(6), humeral implant, commercial code 9617.99.043 - lot #1911366 - ster.1900254.

Event Description

Intraoperative issue due to product malfunctioning occurred on may 31st 2023.The malfunctioning was detected during an elbow revision performed due to a custom-made implant loosening that involved cmd 17-1277 humeral implant.This event was registered as internal complaint no.(b)(4) and reported to the fda with mrf 3008021110-2022-00122.A new custom-made implant, (b)(6) was requested at that time.During the revision surgery performed on (b)(6) 2023, using the manufacturer's instrumentation, the axle pin could not be disengaged from the components.The components involved are: screwdriver shaft for axle, commercial code 9015.90.006 - lot # 22bq06y.Cmd 17-1277 humeral implant, commercial code 9617.99.043 - lot #1911366 - ster.1900254.The screw head was stripped.For this reason, the decision was made to proceed with removal of the modular ulnar body.The surgery was prolonged by more than 15 minutes due to this issue.Previous surgery date - (b)(6) 2019.Patient - female date of birth - 22- june -1961.Event happened in united states.

Manufacturer Narrative

Investigation: checking the manufacturing charts of the involved lot # 22bq06y, no preexisting anomaly was found on the device.Therefore, the product with this lot # has been properly manufactured before being placed on the market.We have received the instrument back for further investigation, which is currently ongoing.Despite we have already submitted a combined initial-final mdr for this event, since the instrument has been returned, we decided to document the investigation on this instrument by follow up mdr.We will submit the subsequent follow up report once the investigation is complete.

Event Description

Intraoperative issue due to product malfunctioning occurred on (b)(6) 2023.The malfunctioning was detected during an elbow revision performed due to a custom-made implant loosening that involved cmd 17-1277 humeral implant.This event was registered as internal complaint no.(b)(4) and reported to the fda with mrf 3008021110-2022-00122.A new custom-made implant, cmd 22-1375 was requested at that time.During the revision surgery performed on (b)(6) 2023, using the manufacturer's instrumentation, the axle pin could not be disengaged from the components.The components involved are: screwdriver shaft for axle, commercial code 9015.90.006 - lot number: 22bq06y cmd 17-1277 humeral implant, commercial code 9617.99.043 - lot number: 1911366 - sterilization number: 1900254.The screw head was stripped.For this reason, the decision was made to proceed with removal of the modular ulnar body.The surgery was prolonged by more than 15 minutes due to this issue.Previous surgery date: on (b)(6) 2019.Patient is a female, date of birth: on (b)(6) 1961.Event happened in united states.

Manufacturer Narrative

Investigation: checking the manufacturing charts of the involved lot number: 22bq06y, no preexisting anomaly was found on the device.Therefore, the product with this lot number has been properly manufactured before being placed on the market.Despite we have already submitted a combined initial-final mdr for this event, since the instrument has been returned, we decided to document the investigation on this instrument by follow up mdr.The instrument returned underwent the internal investigation.This analysis highlighted that the most probable root cause of the issue was an overload, exerted on the instrument.Considering that: checking the manufacturing charts of the involved lot number: 22bq06y, no preexisting anomaly was found on the device the internal investigation highlighted that the root cause of the issue was an overload exerted on the instrument during its use we can conclude that the event is not product related.Pms data: according to the relevant pms data, we have received a total of two complaints related to similar issues.Limacorporate will continue monitoring the market to promptly detect any further case.This is the final mdr.

• Brand Name: SCREWDRIVER SHAFT FOR AXLE
• Type of Device: T15 SCREWDRIVER SHAFT WITH ZIMMER CONNECTION
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: . . ; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 17648149
• MDR Text Key: 322246076
• Report Number: 3008021110-2023-00102
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 9015.90.006
• Device Lot Number: 22BQ06Y
• Is the Reporter a Health Professional?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female