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

Catalog Number	01.32.10.1154
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 08 april 2019: lot 1654045: (b)(4) items manufactured and released 10 april 2017.No anomalies related to the problem.To date, three similar events have been reported on this lot.Visual inspection performed by r&d (b)(4): the impaction plate was found broken in the connection between central pivot and locking disc, causing the separation of the plastic bottom from the metal plate.The event could be related to an high torsion force applied to the disc during the disassembly from the shell.
Event or Problem Description
During primary hip surgery, the 54mm impaction plate broke, during impaction, in the connection between central pivot and locking disc, causing the separation of the plastic bottom from the metal plate.No fragments fell into the patient's wound and there was no delay in the case.The surgery was completed successfully.

• Brand Name: MPACT IMPACTION PLATE DMG
• Common Device Name: SURGICAL INSTRUMENT FOR HIP SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8503590
• Report Number: 3005180920-2019-00269
• Device Sequence Number: 16586280
• Product Code: LXH
• UDI-Device Identifier: 07630040753685
• UDI-Public: 07630040753685
• 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): 04/11/2019

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 Expiration Date: 04/10/2017
• Device Catalogue Number: 01.32.10.1154
• Device Lot Number: 1654045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 04/11/2019
• 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