MAUDE Adverse Event Report: LIMACORPORATE S.P.A AXLE SMALL

Model Number 1590.15.010

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2022

Event Type  malfunction  

Manufacturer Narrative

The specific axle small version implanted (002) is not 510k cleared: shipment of the component and subsequent implantation was a result of a human error.The company is currently trying to recover as much information as possible to promptly investigate and correct the issue (capa to be performed).We will send a final mdr once the investigation will be completed.

Event Description

No intra-operative nor post operative issue: the axle small 9159015010002 axle #small, lot 2115522, ster 2100241 implanted during the revision surgery of elbow prosthesis performed on (b)(6) 2022 (performed due to unknown reason and reported to fda as per mfr 3008021110-2022-00070 - limacorporate complaint #195/22) is not fda cleared.In details, the commercial code related to the axle (1590.15.010) is 510k cleared but the specific version (002) of the part is not fda cleared.Event happened in us.

Manufacturer Narrative

The specific axle small version implanted (002) is not 510k cleared: shipment of the component and subsequent implantation was a result of a human error.The internal analysis highlighted there was a human error in sending a total of n.5 axle components with product code 9159015010002 after requests of us market to have n.5 axle components for proceeding with standard revision surgeries.The detail of the investigation and the relevant risk assessment are described in the document "voluntary action tema elbow - patient monitoring action" shared with the fda on january 25th 2023.Fda recall number: z-1261-2023 to be added (lima ref.(b)(4)) pms data according to the relevant pms data, a total of 30 pieces belonging to product code 9159015010002 were made available on the market and three of them were implanted.Complete traceability given to fda through the document "rationale for voluntary recall" lima corporate will continue monitoring the market to promptly detect any further similar issue.This is a final mdr.

Event Description

No intra-operative nor post operative issue: the axle small 9159015010002 axle #small, lot 2115522, ster 2100241 implanted during the revision surgery of elbow prosthesis performed on (b)(6) 2022 (performed due to unknown reason and reported to fda as per mfr 3008021110-2022-00070 - limacorporate complaint #(b)(4) is not fda cleared.In details, the commercial code related to the axle (1590.15.010) is 510k cleared but the specific version (002) of the part is not fda cleared.Event happened in us.

• Brand Name: AXLE SMALL
• Type of Device: AXLE SMALL
• 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
• MDR Report Key: 15320050
• MDR Text Key: 305517348
• Report Number: 3008021110-2022-00071
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1590.15.010
• Device Catalogue Number: 1590.15.010
• Device Lot Number: 2115522
• Is the Reporter a Health Professional?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1261-2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Male