MAUDE Adverse Event Report: Limacorporate S.p.A PHYSICA Instrument Set; Femoral Positioner Inserter/Extractor

Model Number	9065.88.120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No pre-existing anomaly was detected by checking the manufacturing charts of the lot number 17ag083.We will submit a final report as soon as the investigation is complete.
Event or Problem Description
During a knee surgery performed on (b)(6) 2025, the screw from the femoral positioner fell out during implantation of femur.The instrument involved in the event is the following: physica - femoral positioner (part code 9065.88.120, lot number 17ag083).The screw was noticed on the post-op x-rays.Then the surgeon decided to take the patient back to or to retrieve the screw.The patient is a male, date of birth (b)(6) 1952.The event happened in the united states.

• Brand Name: PHYSICA Instrument Set
• Common Device Name: Femoral Positioner Inserter/Extractor
• Manufacturer (Section D): Limacorporate S.p.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 21374165
• Report Number: 3008021110-2025-00006
• Device Sequence Number: 8598769
• Product Code: JWH
• UDI-Device Identifier: 08033390097956
• UDI-Public: 08033390097956
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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: 17AG083
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: 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: 02/13/2025
• Supplement Report FDA Received Date: 09/28/2026
• 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
• Patient Sex: Unknown