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

Catalog Number	11.01001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information received on 03 august 2017 and includes: no critical delay.Batch review performed on 22 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, this is the first item sold of the lot.
Event or Problem Description
During the pin impaction, the pin adapter broke.The surgery was completed successfully using the metallic pin adapter and the metallic 4 in 1 cutting guide.
Additional Manufacturer Narrative
On 12 september 2017 the r&d project manager performed a visual inspection of the retrieved items and commented as follows: the breakage of the anterior flap of the pin adapter was probably caused due to lateral force or not proper alignment between the instrument and the fixation pins (the lateral fixation holes of the cutting block are oblique).A second cause could be that the surgeon started with the motorized rotation before the proper engagement with the pin head; in this situation the torque is improperly transferred between the adapter and the pin.

• Brand Name: GMK EFFICIENCY - PIN ADAPTER
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6819966
• Report Number: 3005180920-2017-00477
• Device Sequence Number: 10889071
• Product Code: LXH
• UDI-Device Identifier: 07630030877414
• UDI-Public: 07630030877414
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 09/28/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2017
• Supplement Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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: 68 YR
• Patient Weight: 70