MAUDE Adverse Event Report: LIMACORPORATE S.P.A. REVISION HIP; MANUAL IMPACTOR

Model Number	MANUAL IMPACTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No pre existing anomaly was detected by the check of the device history records of the lot number involved.This is the first and only complaint on this lot number.We will submit a final report after the conclusion of the investigation.
Event or Problem Description
During a surgery on (b)(6) 2025, the tip of the revision - manual impactor (product code: 9038.10.305 - lot: 18aq10r) broke inside the stem, the threaded tip remained stuck and was then removed with other available insturments, causing over 30 minutes of prolonged surgery time.Event occurred in italy.

• Brand Name: REVISION HIP
• Common Device Name: MANUAL IMPACTOR
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova; san daniele del friuli, udine 33038
• MDR Report Key: 23002119
• Report Number: 3008021110-2025-00120
• Device Sequence Number: 13141379
• Product Code: LPH
• UDI-Device Identifier: 08033390112628
• UDI-Public: 08033390112628
• Combination Product (Y/N): N
• PMA/510(K) Number: FDA PREMARKE
• 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
• Report Date (Section B): 09/08/2025

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: MANUAL IMPACTOR
• Device Catalogue Number: 9038.10.305
• Device Lot Number: 18AQ10R
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 09/09/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown