MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA SYSTEM; HEADED SCREW DIA. 3 MM X L. 50 MM

Model Number	9095.11.D50
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Checking the dhrs of the lot # involved in the complaint, no pre-existing anomaly was found on the instruments manufactured with lot# 19at07y.A final report will be submitted once the investigation will be concluded.
Event or Problem Description
During knee surgery performed on (b)(6) 2021, the exagonal head screw dia.3x50 mm (product code 9095.11.D50, lot #19at07y) got stuck with the powered pin driver exagonal head (product code 9095.11.121, lot# 19ag08l).According to the complaint source, pliers were used to remove the pins.Surgery was prolonged of 20 minutes.
Event or Problem Description
During knee surgery performed on (b)(6) 2021, it was not possible to unscrew the pin exagonal head screw dia.3x50 mm (product code 9095.11.D50, lot 19at07y).The issue occurred during use with the powered pin driver exagonal head (product code 9095.11.121, lot 19ag08l).According to complaint source, patient's bone was hard.The pin was then removed using forceps and the surgery was extended by 20 minutes.Event occurred in italy.Note: this complaint was reported to fda as the pin is fda cleared.However, in this case it was used in combination with a powered pindriver during a physica zuk knee surgery, which is not commercialized in the usa.
Additional Manufacturer Narrative
No pre-existing anomalies were detected by the check of the device history records of the pin with lot 19at07y.The device history records of the pindriver with lot 19ag08l were also checked without finding pre-existing anomalies.The affected pin was not available to be returned, therefore no specific analysis could be performed on it.The pindriver was not returned either, as the complaint source confirmed it was functional and the problem affected the pin only.According to the event description, we believe that the cause of the issue is most probably related to pin wear, leading to the reported connection issues with the pin driver.Following repeated uses, the pin might in fact get worn at the level of the connection with the pin driver, consequently the connection might result unstable and cause the reported difficulty.It should be considered that, as stated in limacorporate instruments instruction for use, the instruments are reusable devices and should be carefully inspected for damage or wear and not used if malfunctioning or defect is found.Pms data: based on limacorporate pms data, we estimate an occurrence rate of connection issues between the pin and physica zuk pindriver lower than 0.01%.No corrective actions needed following this complaint.Limacorporate will continue monitoring the market to promptly detect any further similar event.

• Brand Name: PHYSICA SYSTEM
• Common Device Name: HEADED SCREW DIA. 3 MM X L. 50 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 11560626
• Report Number: 3008021110-2021-00016
• Device Sequence Number: 11583211
• Product Code: LXH
• UDI-Device Identifier: 08033390123693
• UDI-Public: 08033390123693
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: 9095.11.D50
• Device Catalogue Number: 9095.11.D50
• Device Lot Number: 19AT07Y
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 10/03/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown