MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK EFFICIENCY BASE INSERT FOR PATELLA CLAMP; SURGICAL INSTRUMENT FOR KNEE SURGERIES

Catalog Number	11.00005
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 21 february 2019: set ref (b)(4), lot 186526: (b)(4) items manufactured and released on 07-aug-2018 expiration date: 2023-07-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.As regards the semifinished lot: mat25760, another event has been reported on the same broken part.Visual inspection performed by r&d product manager: the visual inspection confirmed what reported into the complaint form.The instrument damage could have been reasonably caused by improper use, such as trying to remove the patella clamp before to have completely disengaged the base with spikes from the bone.
Event or Problem Description
After the patella implantation, the surgeon noticed that 2 out of 4 spikes of the base insert for patella clamp were broken.Missing pins were found around patient patella and tendon.The surgeon was able to retrieve the pins from the patient's body.

• Brand Name: GMK EFFICIENCY BASE INSERT FOR PATELLA CLAMP
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE SURGERIES
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8358045
• Report Number: 3005180920-2019-00076
• Device Sequence Number: 16652792
• Product Code: LXH
• UDI-Device Identifier: 07630030877384
• UDI-Public: 07630030877384
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2019

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 Expiration Date: 07/19/2023
• Device Catalogue Number: 11.00005
• Device Lot Number: 186526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/21/2019
• 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