MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA INSTRUMENT SET; FEMORAL TRIAL/PS BOX GUIDE INSERTER/EXTRACTOR

Model Number	9065.88.140
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During a knee surgery performed in korea, the femoral trial holder / ps box guide (9065.88.140 lot.21bg04l) was damaged during the hammering process while in use.The broken fragments were retrieved from the surgical site.The handle functioned normally, and the surgery was completed using an alternative instrument.Surgery was prolonged 30-40 minutes.Even has occurred in south korea.
Additional Manufacturer Narrative
Investigation: a review of the device history records (dhrs) for the involved lot #21bg04l was performed.No pre-existing anomalies were identified on the 10 devices manufactured within the same lot.This is the first and only complaint received related to this lot.A final mdr will be submitted once the investigation is completed.

• Brand Name: PHYSICA INSTRUMENT SET
• Common Device Name: FEMORAL TRIAL/PS BOX GUIDE INSERTER/EXTRACTOR
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24579795
• Report Number: 3008021110-2026-00167
• Device Sequence Number: 9323664
• Product Code: JWH
• UDI-Device Identifier: 08033390103572
• UDI-Public: 08033390103572
• Combination Product (Y/N): N
• PMA/510(K) Number: K141934
• 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

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: 9065.88.140
• Device Catalogue Number: 9065.88.140
• Device Lot Number: 21BG04L
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown