MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT IMPACTION PLATE DMH; SURGICAL INSTRUMENT FOR HIP

Catalog Number	01.32.10.1156
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection performed by r&d (b)(4): the locking disc detached from the plate, avoiding the retention of the plastic bottom which slightly separated from the shell.A possible root cause can be related to an high torsion provided to the screw during the disengagement from the shell that provided to the locking disc failure.Batch review performed on 01 april 2019: lot 1654046: (b)(4) items manufactured and released on 17-may-2017.No anomalies found related to the problem.To date, no similar event has been reported.
Event or Problem Description
During the primary hip surgery and after impacting the cup, it was discovered that the impaction plate broke and a fragment fell into the patient.The surgeon was able to remove the fragment and the case was delayed by 3-minutes.The surgery was completed successfully.

• Brand Name: MPACT IMPACTION PLATE DMH
• Common Device Name: SURGICAL INSTRUMENT FOR HIP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8482792
• Report Number: 3005180920-2019-00236
• Device Sequence Number: 16619371
• Product Code: LXH
• UDI-Device Identifier: 07630040753692
• UDI-Public: 07630040753692
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 01.32.10.1156
• Device Lot Number: 1654046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other