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 04/29/2022

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

Patient underwent initial surgery for tema elbow on (b)(6) 2022.During this surgery the following components have been implanted: ulnar stem #u6, ulnar body small, ulnar liner - small, humeral stem #h7, and humeral body - small.A revision surgery for unknown reason was then performed on (b)(6) 2022: existing implants were linked with a axle #small, product code 1590.15.010, lot 2115522, ster 2100241.Unfortunately, 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.

Event Description

Patient underwent initial surgery for tema elbow on (b)(6) 2022.During this surgery the following components have been implanted: ulnar stem #u6, ulnar body small, ulnar liner - small, humeral stem #h7, and humeral body - small.A revision surgery for unknown reason was then performed on (b)(6) 2022: existing implants were linked with a axle #small, product code 1590.15.010, lot 2115522, ster 2100241.Unfortunately, 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 (b)(6) 2023.Fda recall number: z-1261-2023 (lima ref.(b)(4) in addition to the patient monitoring action, a corrective action and preventive action (q20230002) was opened to reduce the risk of recurrence of similar issues, including a sensitization to make the internal operators aware of the importance to carefully follow internal procedures.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.

• 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: 15315869
• MDR Text Key: 304092545
• Report Number: 3008021110-2022-00069
• 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: 08/29/2022
• 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: 83 YR
• Patient Sex: Female