MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA RESURFACING PATELLA INSTRUMENT 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	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 21 march 2019: resurfacing patella instrument set ref 11.00005, lot 186526: (b)(4) items manufactured and released on 07-aug-2018.No anomalies found related to the issue.To date, (b)(4) items of this lot have already been sold, with three other similar events registered (complaint (b)(4) [mdr 2019-00076]; complaint (b)(4) [mdr 2019-00118] and complaint (b)(4)].As regards the mat25760 [gmk efficiency 77.11.0606 cement cup for patella clamp], this is the 4th case of breakage of the involved part of the instrument (spikes), the complaints in object are the same listed above for the set lot.One other device was involved in the complaint: batch review performed on 22 march 2019: resurfacing patella instrument set ref 11.00005, lot 186526: (b)(4) items manufactured and released on 07-aug-2018.No anomalies found related to the issue.To date, (b)(4) items of this lot have already been sold, with four other similar events registered (complaint (b)(4); complaint (b)(4) [mdr 2019-00118] ; complaint (b)(4)].As regards the mat22471 [gmk efficiency 77.11.0601 patella clamp], this is the 10th case of breakage of the involved part of the instrument (lever).As regards the mat24105 [gmk efficiency 77.11.0601 patella clamp], this is the 5th case of breakage of the involved part of the instrument (lever).Note: in five cases, both these mat have been considered as involved because both of them were part of the involved set lot 186526, so, the mat22471 has been involved for sure in 5 cases, while the other 5 are not confirmable and considering mat24105, none of the cases is confirmable.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.In order to prevent the risk of damage due to improper use, such as the removal of the patella clamp before the complete disengage of the base with spikes from the bone, a new design modification will be introduced.During the visual inspection, the blue lever has been found a little bit broken on the tip and deformed at the base.The blue rack locking button is broken resulting in a loss of the locking function of the patella clamp.The root cause is likely a limitation of the design parameters with regard to specific conditions of use.
Event or Problem Description
After the cementation, the surgeon removed the patella clamp and discovered that 3 spikes of the base insert for patella clamp were completely broken.The surgeon was able to retrieve the broken pins from the patient body.

• Brand Name: RESURFACING PATELLA INSTRUMENT SET
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8443623
• Report Number: 3005180920-2019-00181
• Device Sequence Number: 3013517
• 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): 03/22/2019

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: 07/19/2023
• Device Catalogue Number: 11.00005
• Device Lot Number: 186526
• 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: 02/20/2019
• Initial Report FDA Received Date: 03/22/2019
• 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