MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PATELLA RESURFACING SET; SURGICAL INSTRUMENT FOR KNEE SURGERY

Catalog Number	11.00005
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 17 june 2019: resurfacing patella instrument set ref 11.00005, lot 188366: (b)(4) items manufactured and released on 06 july 2017.Expiration date: 2022-06-05.No anomalies found related to the issue.To date, (b)(4) items of this lot have already been sold.As regards the mat25760 of the code 77.11.0606: (b)(4) items released on 19 june 2018, with 11 similar cases involving this lot.Preliminary investigation performed by r&d project manager: 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 implantation, the surgeon noticed that 1 out of 4 spikes of the base insert for patella clamp was missing.Missing pin found around patient patella and tendon.The surgeon was able to retrieve the pin from the patient body.
Additional Manufacturer Narrative
Visual inspection performed by medacta knee r&d project 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.The mat of the patella base is part of a second design (managed with mr 146-17) and already in force.With this modification the spike has been reinforced on the base adding bigger radius.Moreover, in order to prevent the risk of damage due to improper use, such as the removal of the patella clamp before the complete disengage of the base with spikes from the bone, a further change has been implemented with mr130-19 changing the angle of the spikes with significantly increasing of the resistance section.

• Brand Name: PATELLA RESURFACING SET
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8711135
• Report Number: 3005180920-2019-00481
• Device Sequence Number: 2021418
• 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,Followup
• Report Date (Section B): 06/19/2019

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: 06/05/2022
• Device Catalogue Number: 11.00005
• Device Lot Number: 188366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 07/25/2019
• 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