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

Catalog Number	11.00005
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on (b)(4) 2019: lot 177066: (b)(4) items manufactured and released on 11/10/2017.Expiration date: 10/26/2017.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 specific screw lot: mat22881, another similar event has been reported visual inspection performed by r&d product manager the piece analyzed during the visual inspection has three fixation spikes damaged (instead of only one as reported into the event description); the sales representative confirmed that during the surgery only one spike broke but the instrument was probably further damaged after the surgery by the (b)(6) logistic team to inadequate procedure.
Event or Problem Description
After the implantation the surgeon noticed that 1 out of 4 spikes of the base insert for patella clamp was broken.Missing pin was found around the patient's patella and tendon.

• Brand Name: GMK EFFICIENCY -BASE INSERT FOR PATELLA CLAMP
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8338978
• Report Number: 3005180920-2019-00054
• Device Sequence Number: 2229062
• 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): 02/14/2019

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: 10/26/2017
• Device Catalogue Number: 11.00005
• Device Lot Number: 177066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/14/2019
• 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