MAUDE Adverse Event Report: LIMACORPORATE SPA PHYSICA FEMORAL INSERTER

Model Number 9065.88.120

Device Problem Partial Blockage (1065)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

No pre-existing defects were found by checking the manufacturing charts of the lot# of instrument involved (17ag093).We will proceed with further investigation and send a final report once the investigation will be concluded.

Event Description

During surgery, the golden screw of physica femoral positioner was blocked.The surgeon was forced to use the 2nd impactor of the set (9065.88.220) to insert the femoral component.Event occured in (b)(6).

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was found on the instruments that belong to the same lot number (17ag093), thus we can state that the instrument was released on the market compliant specifications.This is the first and only complaint received on this lot number.The specific instrument involved was received by limacorporate for analysis.The first inspection confirmed that the instrument was blocked, after a few attempts we were able to unscrew it.Once unscrewed it was noted that the screw functionality was restored as it was possible to screw and unscrew the instrument without experiencing any further issue.The visual analysis of the threaded body did not highlight any defect that could have contribute to the reported issue.After the inspection of the instrument, we speculate that the reported difficulty to unscrew the instrument might have been related to the following causes: - repeated use of the instrument and specifically to the deposit of residues/debris in the interstices, which may have caused the mechanism to block and thus the instrument to loose functionality until forcedly unscrewed and/or - an excessive force applied during the use, when the subcomponent was at end-stop position.Pms data: limacorporate is aware of three similar complaints (including the one object of this report) about the intra-operative difficulty to unscrew the femoral positioners with code 9065.88.120.By the inspection of the two (out of three) instruments that we could analyze, no product defect that could have contributed to this problem was found.No corrective action related to this complaint.Limacorporate will continue monitoring the market to promptly detect any further similar event.

Event Description

Intra-operative issue occurred on (b)(6) 2018 during a knee surgery: the screw of the femoral positioner with code 9065.88.120 and lot# 17ag093 was blocked.According to the information received the surgery was then completed without any prolongation of the surgical time, as the surgeon was able to conclude with the help of another available instrument.The exact number of uses of the instrument is unknown, but the complaint source estimated an average of 4-5 uses.This event occurred in spain.

• Brand Name: PHYSICA FEMORAL INSERTER
• Type of Device: PHYSICA FEMORAL INSERTER
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 7587125
• MDR Text Key: 111095315
• Report Number: 3008021110-2018-00040
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• PMA/PMN Number: K141934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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
• Device Model Number: 9065.88.120
• Device Lot Number: 17AG093
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1