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	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 29 apr 2019: resurfacing patella instrument set ref (b)(4), lot 188366: (b)(4) items manufactured and released on 26-oct-2018.Expiration date 2022-06-05.No anomalies found related to the issue.To date, (b)(4) items of this lot have already been sold, with 2 other similar events registered ((b)(4)).As regards the (b)(4), this is the 7th case of breakage of the involved part of the instrument (spikes), the complaints in object are ((b)(4)).
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 was broken (the broken piece has been retrieved from the patient), the remaining 3 spikes seem to be bend.The surgeon was able to retrieve the broken spike from the patient body.The surgeon cuts patella without any guide and pokes peg holes through a blue guide.
Additional Manufacturer Narrative
Visual inspection performed by 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.

• 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: 8573530
• Report Number: 3005180920-2019-00331
• Device Sequence Number: 11214929
• 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): 05/29/2019

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: 05/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 05/29/2019
• 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