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	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 04 jun 2019.Resurfacing patella instrument set ref 11.00005, lot 187487: (b)(4) items manufactured and released on 26-oct-2018.Expiration date: 2023-10-14.No anomalies found related to the issue.To date, (b)(4) items of this lot have already been sold, without any other similar event registered.As regards the mat25760, this is the 10th case of breakage of the involved part of the instrument (spikes), the complaints in object are: [mdr 2019-00076]; [mdr 2019-00118]; [mdr 2019-00181]; [mdr 2019-00199]); [mdr2019-00264]; [mdr2019-00293]; [mdr2019-00331]; and complaint (b)(4)).Visual inspection 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 cementation, the surgeon removed the patella clamp and discovered that 3 out of 4 spikes of the base insert for the patella clamp were broken.The surgeon was able to retrieve the broken spikes from the patient body.Due to this event the surgery was prolonged about 5 minutes.

• 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: 8670157
• Report Number: 3005180920-2019-00444
• Device Sequence Number: 13917645
• 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): 06/05/2019

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: 10/14/2023
• Device Catalogue Number: 11.00005
• Device Lot Number: 187487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 06/05/2019
• 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