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	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 23 april 2019: lot 1551143: (b)(4) items manufactured and released on 11-sep-2015.No anomalies found related to the issue.To date, no other similar event has been reported on this lot.Preliminary investigation performed by (b)(4): from the photo it is possible to note the impaction plate broken, with the plastic bottom damaged and partially separated from the metal plate.The root cause can be related to the breakage of the central screw/locking disc connection that maintains the instrument assembled, probably occurred during an high torsion applied to the screw.
Event or Problem Description
During the primary hip surgery and after impacting the cup, it was discovered that the impaction plate had broken during impaction.No fragments fell into the patient's surgical wound and there was no delay in the case.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the plastic bottom detached from the metal shell due to the breakage of the connection between central screw and locking disc.The event is probably related to an high torsion applied to the instrument during the disassembly.

• 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: 8548600
• Report Number: 3005180920-2019-00316
• Device Sequence Number: 1639633
• Product Code: LXH
• UDI-Device Identifier: 07630040753692
• UDI-Public: 07630040753692
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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: 1551143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/22/2019
• 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