MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK EFFICIENCY - IMPACTOR HANDLE; SURGICAL INSTRUMENT FOR KNEE

Catalog Number	11.01001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 28 august 2017.Lot 174244: (b)(4) items manufactured and released on 07 july 2017.Expiration date: 2022-06-27.No anomalies found related to the problem on (b)(4).To date, (b)(4) items of the same lot have been already sold without any similar reported event.On 01 september 2017 the r&d project manager performed a preliminary investigation based on the available picture and commented as follows: basing on the event description, it seems that the surgeon, once performed a first complete tibia preparation of the bone, decided to perform a +2mm correction cut to the tibia.After this second cut, the reaming step to properly prepare the tibia again, was not performed.The handle was used to impact the keel into the bone without having before properly prepared the bone to sit the trial keel.The impactor handle was used in condition not foreseen by the surgical technique.The impaction force required to sit the trial keel into the bone (furthermore into an hard sclerotic bone) without having before prepared the bone with the dedicated reamer was too high and brought to the breakage of the divide.No further considerations can be done looking at the picture.
Event or Problem Description
The patient had hard sclerotic bone.The surgeon prepared tibia accordingly.Upon range of motion, surgeon decided to take additional 2mm of tibia.After doing so, the surgeon proceeded to place gmk-efficiency tibia plate back on and did not reprepared the tibia with metal reamer.The surgeon tapped the gmk-efficiency tibial cruciate into place.It took several attempts to seat properly.Upon going through range of motion and surgeon satisfaction, the surgeon attempted to remove the gmk-efficiency tibial plate and cruciate.First attempt, done with a gmk-efficiency handle failed, with plastic attachment piece for cruciate breaking.The second attempt, done with new gmk-efficiency handle failed, with plastic attachment piece for cruciate breaking.The surgeon then used osteotome to lift the plate and cruciate together from the tibia, loosening the cruciate from the tibia.Pieces were removed.The surgeon prepared the tibia with metal reamer and gmk-efficiency cruciate again and proceeded to cement components for the total knee.The delay was approximately 2-3 minutes.Instruments are not available.

• Brand Name: GMK EFFICIENCY - IMPACTOR HANDLE
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6837579
• Report Number: 3005180920-2017-00486
• Device Sequence Number: 1117357
• Product Code: LXH
• UDI-Device Identifier: 07630030877414
• UDI-Public: 07630030877414
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2017

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: 06/27/2022
• Device Catalogue Number: 11.01001
• Device Lot Number: 174244
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 09/01/2017
• 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