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

Catalog Number	11.01002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was not possible from the field identify if the impactor handle is from the lot 174253 or from the lot 176998 (both set available during surgery contained the impactor handle).For this reason the document review has been done on both the possible lots.Batch review performed on 27 november 2017: lot 174253: (b)(4) items manufactured and released on 13 july 2017.Expiration date: 2022-06-20.No anomalies found related to the problem on mat22008.To date, (b)(4)items of the same lot have been already sold without any similar reported event.Lot 176998: 20 items manufactured and released on 11 october 2017.Expiration date: 2022-10-02.No anomalies found related to the problem on mat16745.To date, 15 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The impactor handle tip broke off in the keel punch a secondary instrument was used to remove the keel punch from the patient.There was a short delay of approximately 2 minutes.The surgery was completed successfully.

• 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: 7067356
• Report Number: 3005180920-2017-00707
• Device Sequence Number: 1260160
• Product Code: LXH
• UDI-Device Identifier: 07630030882890
• UDI-Public: 07630030882890
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2017

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: 06/20/2022
• Device Catalogue Number: 11.01002
• Device Lot Number: 174253
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/29/2017
• 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
• Patient Age: 69 YR