MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK EFFICIENCY LONG SMOOTH PINS; SURGICAL INSTRUMENT FOR KNEE

Catalog Number	11.00008
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 18 march 2019: lot 187479: (b)(4) items manufactured and released on 13-sep-2018.Expiration date: 2023-08-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Visual inspection performed by r&d project manager: the long smooth pin used during the femur sizing have been used in combination with motorized device.The pin is not suitable to be motorized since it is not provide with cut edges and threaded feature.In this case, signs of damage are visible on the tip of the pin due to improper use.The blockage of the pin into the drilling guide was probably caused due to excessive force applied to allow the pin insertion; in this situation, overheating is generated due to the friction between the pin and the drilling guide with the risk of cold welding phenomenon.
Event or Problem Description
During the primary knee surgery and while sizing the femur, the smooth pin began to disintegrate and became wedged inside the femoral sizing guide.It is unknown if any metal shavings from the pin fell inside of the patient.The surgeon already had two pins placed into the sizing guide and was able to slide the cutting block onto the pins and size the femur.This issue caused a 2-minute delay in the case and the surgery was completed successfully.A motorized instrument was used to insert the pin.

• Brand Name: GMK EFFICIENCY LONG SMOOTH PINS
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8436838
• Report Number: 3005180920-2019-00162
• Device Sequence Number: 11275655
• Product Code: LXH
• UDI-Device Identifier: 07630030842733
• UDI-Public: 07630030842733
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2023
• Device Catalogue Number: 11.00008
• Device Lot Number: 187479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other