MAUDE Adverse Event Report: LIMACORPORATE S.P.A T15 SCREWDRIVER SHAFT

Model Number 9015.90.005

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

Checking the manufacturing charts of the involved lot # 20bq0d0, no pre-existing anomaly was found.This is the first and only complaint received on this lot #.We submit a final report as soon as the investigation is complete.

Event Description

During an elbow revision surgery performed on (b)(6), 2023.When starting to remove the axle the surgeon noticed that the screwdriver did not fit into the head of the axle.Agent/rep confirmed that the instrument fit and could not turn the axle and when a lot of force was placed on the instrument it failed.According to the received information, the surgical time was delayed by 30 minutes due to the issue.Instrument details t15 screwdriver shaft, commercial code #9015.90.005 - lot #20bq0d0 - ster.# n/a.The surgery was successfully completed.Previous surgery date (b)(6) 2022.Patient is a male.Date of birth (b)(6) 1958.Event happened in the us.

Manufacturer Narrative

Investigation: checking the manufacturing charts of the involved lot # 20bq0d0, no pre-existing anomaly was found.This is the first and only complaint received on this lot #.Instrument analysis the instrument along with the damaged explanted implant were returned to limacorporate for analysis.Further analysis checking the dhr's shows dimensions, material, and heat treatment compliant ().Review of the returned axle implant 9617.25.30k, lot number 2211499 that this instrument was used on was found worn and the internal evaluation highlighted that there is a high probability the got stuck and when they tried to remove it, they broke the instrument.Ultimately and as hypothesized, the breakage is attributable to use.Based on the information and investigation we can consider that.Checking the manufacturing charts of the involved lot # 20bq0d0, no pre-existing anomaly was found.Review of the returned axle implant 9617.25.30k, lot number 2211499 that this instrument was used on was found worn and the internal evaluation highlighted that there is a high probability the got stuck and when they tried to remove it, they broke the instrument.We can hypothesize that unexpected stresses have been applied, leading to the instrument's breakage.This was the first case here we experience what the team think is a cold-welding phenomenon of the axle, that has been currently resolved with the release of the new version (v3) of tema components.In addition, during this surgery, the new taper breaker instruments weren't available as they've been deployed together with the new tema v03 release.Based on the data received and analysis performed we can suppose this event was not instrument related.Pms data according to our pms data, this is the only complaint of breakage of t15 screwdriver shaft, commercial code 9015.90.005.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 issues.

Event Description

During an elbow revision surgery performed on (b)(6) 2023.When starting to remove the axle the surgeon noticed that the screwdriver did not fit into the head of the axle.Agent/rep confirmed that the instrument fit and could not turn the axle and when a lot of force was placed on the instrument it failed.According to the received information, the surgical time was delayed by 30 minutes due to the issue.Instrument details t15 screwdriver shaft, commercial code #9015.90.005 - lot #20bq0d0 - ster.# n/a.The surgery was successfully completed.Previous surgery date (b)(6) 2022; patient is a male; date of birth (b)(6) 1958; event happened in the us.

• Brand Name: T15 SCREWDRIVER SHAFT
• Type of Device: T15 SCREWDRIVER SHAFT
• 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: 16741531
• MDR Text Key: 313305784
• Report Number: 3008021110-2023-00034
• 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
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 9015.90.005
• Device Catalogue Number: 9015.90.005
• Device Lot Number: 20BQ0D0
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2024
• 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
• Patient Age: 65 YR
• Patient Sex: Male