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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE PUNCHER SIZE 3-4 - HINGE; SURGICAL INSTRUMENT FOR KNEE SURGERY
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MEDACTA INTERNATIONAL SA GMK-HINGE PUNCHER SIZE 3-4 - HINGE; SURGICAL INSTRUMENT FOR KNEE SURGERY Back to Search Results
Catalog Number 02.09.10.0102
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/15/2019
Type of Reportable Event Malfunction
Additional 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 or Problem 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.
 
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Brand Name
GMK-HINGE PUNCHER SIZE 3-4 - HINGE
Common Device Name
SURGICAL INSTRUMENT FOR KNEE SURGERY
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9030694
Report Number3005180920-2019-00765
Device Sequence Number2589457
Product Code LXH
UDI-Device Identifier07630040785631
UDI-Public07630040785631
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
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) 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
Operator of Device Health Professional
Device Catalogue Number02.09.10.0102
Device Lot Number1210553
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/15/2019
Initial Report FDA Received Date09/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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