MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE PUNCHER SIZE 3-4 - HINGE; SURGICAL INSTRUMENT FOR KNEE SURGERY

Catalog Number 02.09.10.0102

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 27 august 2019: lot 1210553: (b)(4) items manufactured and released on 31-oct-2012.No anomalies found related to the problem to date no similar events reported.

Event Description

During the primary knee surgery, the surgeon observed that the size 3-4 puncher was missing the etch marks used to measure the offset.The surgeon was finally able to measure the offset without the etch marks but it caused a 50-minute delay in the case.The surgeon was obliged to release the tourniquet and to wait to put the tourniquet back up to cement.This instrument was from a consignment set.The surgery was completed successfully.

• Brand Name: GMK-HINGE PUNCHER SIZE 3-4 - HINGE
• Type of Device: SURGICAL INSTRUMENT FOR KNEE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 9030694
• MDR Text Key: 213883139
• Report Number: 3005180920-2019-00765
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07630040785631
• UDI-Public: 07630040785631
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/13/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 02.09.10.0102
• Device Lot Number: 1210553
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2012
• 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