MAUDE Adverse Event Report: LIMACORPORATE S.P.A. DELTA CUP - WRENCH; WRENCH FOR CUPS

Model Number 9055.51.015

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the instruments that belong to lot number 17ar08k.A final report will be submitted after the conclusion of the investigation.

Event Description

Intra-operative issue occurred during hip surgery on 12th october 2022: when impacting a delta tt acetabular cup, the threaded tip of the delta cup wrench (code 9055.51.015, lot 17ar085k) broke and remained stuck inside the cup hole.The surgery took 45 minutes more than expected and another cup was implanted.This event occurred in portugal.

• Brand Name: DELTA CUP - WRENCH
• Type of Device: WRENCH FOR CUPS
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via naizonale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via naizonale 52; villanova di san daniele, udine 33038
• MDR Report Key: 15959684
• MDR Text Key: 307837211
• Report Number: 3008021110-2022-00126
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K112898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• 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: 9055.51.015
• Device Lot Number: 17AR08K
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization