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

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	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on march 25, 2019: patella resurfacing set ref 11.00005, lot 178222: 40 items manufactured and released on 10-jul-2018.Expiration date: 2023-06-26.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 of lever breakage (complaint (b)(4)).Another similar reported event of spikes breakage (complaint (b)(4)).In addition, considering the mat of the involved components: considering the patella clamp ref 77.11.0601, lot mat22471 ((b)(4) items), this is the 9th case of breakage of the involved part (lever), as the previous cases were complaints (b)(4).Considering the base insert for patella clamp ref 77.11.0606, lot mat25761, this is the 3rd case of breakage of this specific part (spikes) as the other cases are: complaint (b)(4).Visual inspection performed by r&d project manager: the visual inspection confirms the breakage of the blue rack locking button.The cause probably depends from the design that in particular conditions of use does not guarantee the proper resistance.In addition the analyzed piece has two broken fixation spikes.This kinf of damage could probably occur in case of 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
When the surgeon opened the gmk-efficiency tray, it was noticed that the lock lever of the patella clamp was broken, the surgeon has continued to grip the patella clamp until the cementation.After the cementation, the surgeon removed the patella clamp, and discovered that 1 of the 4 spikes of the base insert for the patella clamp was broken.The surgeon was able to retrieve the pin from the patient body.

• Brand Name: PATELLA RESURFACING SET
• 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: 8460365
• Report Number: 3005180920-2019-00200
• Device Sequence Number: 19240817
• 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): 03/28/2019

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: 06/26/2023
• Device Catalogue Number: 11.00005
• Device Lot Number: 178222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/28/2019
• 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