MAUDE Adverse Event Report: LIMACORPORATE S.P.A. DELTA PF CUP; WRENCH

Model Number	9055.51.015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to lack of product information, the production records review is not possible.A final report will be submitted after the investigation.
Event or Problem Description
The delta cup - wrench (code 9055.51.015, lot unknown) broke during use: during cup impaction of custom-made device 2026-9617-1015, the end engaged in the implant sheared off and could not be retrieved from within the implant.The surgery was completed with no delay, using alternative impactor, the spacer was correctly seated despite the broken instrument tip.This event occurred in uk.

• Brand Name: DELTA PF CUP
• Common Device Name: WRENCH
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 25275495
• Report Number: 3008021110-2026-00239
• Device Sequence Number: 15874477
• Product Code: MBL
• UDI-Device Identifier: 08033390025409
• UDI-Public: 08033390025409
• Combination Product (Y/N): N
• PMA/510(K) Number: K112898
• 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): 05/25/2026

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: 9055.51.015
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown