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	Failure of Implant (1924)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 01 april 2019: patella resurfacing set ref (b)(4), lot 178222: (b)(4) 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 (complaint (b)(4)).Considering the base insert for patella clamp ref (b)(4), 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 (b)(4): the visual inspection confirmed what reported into the complaint form; the locking lever and one pin of the base for patella clamp are broken.In addition we discovered a second pin a little damaged.The locking lever could have been a little damaged during the first closing/opening test before the packaging; in this case, a little crack may not have been detected by the operator.Concerning the damaged pins it can occur mainly in case of improper use, such as trying to remove to remove the patella clamp before to have completely disengaged the base from the bone.
Event or Problem Description
After the cementation, the surgeon removed the patella clamp and discovered 1 out of 4 spikes of the base insert for the patella clamp broken.The surgeon was able to retrieve the broken pin from the body of the patient.We do not report this event to pmda.

• 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: 8478385
• Report Number: 3005180920-2019-00222
• Device Sequence Number: 1432167
• 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): 04/03/2019

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: 03/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 04/03/2019
• 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