MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK EFFICIENCY PATELLA CLAMP; SURGICAL INSTRUMENT FOR KNEE SURGERY

Catalog Number	11.00005
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 05 march 2019: lot 186526 (set ref 11.00005): (b)(4) items manufactured and released on 07-aug-2018.Expiration date: 2023-07-19.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)).As regards the mat22471 and mat24105 (they were both used in this set lot, so it is impossible to define which one is involved in the issue), this is the 6th case of breakage of the involved part of the instrument (lever) for mat22471 [complaints (b)(4)] and the 2nd for mat24105 [complaint (b)(4)].Additional device involved in the complaint gmk efficiency 77.11.0606 base insert for patella clamp lot 186526 (set ref 11.00005): (b)(4) items manufactured and released on 07-aug-2018.Expiration date: 2023-07-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with two other similar reported events (complaint (b)(4))).As regards the mat25760, this is the 3rd case of breakage of the involved part of the instrument (spikes) [(b)(4)].Preliminary investigation performed by r&d project manager: preliminary inspection based on the pictures provided with the complaint.Spikes: the instrument breakage could have been reasonably caused by improper use, such as an attempt in removing the patella clamp before having completely disengaged the base with spikes from the bone.Lock lever: the root cause is likely a limitation of the design parameters with regard to specific conditions of use.The images of the complaint confirm that the blue rack locking button broke during its use, resulting in a loss of the locking function of the patella clamp.
Event or Problem Description
When the surgeon tried to clamp, the lock lever of the patella clamp broke.The surgeon continued to grip the patella clamp until the cementation, after the cementation, the surgeon removed the patella clamp and discovered 3 out of 4 spikes of the base insert were broken.The surgeon was able to retrieve the pins from the patient body.

• Brand Name: GMK EFFICIENCY PATELLA CLAMP
• 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: 8394718
• Report Number: 3005180920-2019-00118
• Device Sequence Number: 1990525
• 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): 03/06/2019

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 03/06/2019
• 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