MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PATELLA INSTRUMENT 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	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection performed by r&d (b)(4): the visual inspection confirms the breakage of the blue rack locking button.In this case, the surgeon detected the breakage before to use the instrument; a possible hypothesis could be that the lock lever broke during the procedure before packaging.The operator always has to completely close the clamp for cleaning; in this phase could be that the lever tooth is damaged till the breakage and the patella clamp is packaged already broken.Nevertheless, from the siscodata images, it was not possible to detect the lack of the lever tooth.In addition the analyzed piece has one fixation spike broken.The spikes damage is mainly caused by improper use, such as trying to remove the patella clamp before to have completely disengaged the base from the bone.Batch review performed on 08 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.Lever breakage: to date, (b)(4) items of the same lot have been already sold with another similar reported event (complaint (b)(4)).Considering the patella clamp ref (b)(4), 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).Spikes breakage: to date, (b)(4) items of the same lot have been already sold with two other similar reported events (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).
Event or Problem Description
When the surgeon opened the patella instrument set discovered that the blue lever of the patella clamp was broken, in spite of this, he used the instrument.After the cementation, the surgeon removed the patella clamp, and discovered 1 out of 4 spike of the base insert for the patella clamp broke.The surgeon was able to retrieve the pins from the patient body.

• Brand Name: PATELLA INSTRUMENT 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: 8498764
• Report Number: 3005180920-2019-00255
• Device Sequence Number: 2594362
• 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): 04/10/2019

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: 03/11/2019
• Initial Report FDA Received Date: 04/10/2019
• 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