MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT IMPACTION PLATE Ø56; SURGICAL INSTRUMENT FOR HIP SURGERY

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	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 21.June.2019: lot 1654046: (b)(4) items manufactured and released 17 may 2017.No anomalies found related to the issue.To date, (b)(4) similar event on the same lot has been registered but the breakage occured on a different zone of the instrument ( emdr 2019-00236).Preliminary investigation performed by r&d project manager: from the received image it appears that the plate was broken separating tooth and the spring from the instrument.From the received information it seems that probably some grip occurred during the unscrewing of the plate from the shell; probably too much force was applied on the instrument that caused the mechanical failure of the device, but from the received information it was not possible to determine with certainty the root cause of the event.Visual investigation performed by r&d project manager: from the received piece it was noticed that the locking disc was removed; due to the lack of the locking, the unscrewing caused the separation of the plastic bottom and the consequent separation og the tooth and the spring.A possible root cause can be related to the excessive torque applied during the unscrewing of the device.
Event or Problem Description
During the primary hip surgery, and after impacting the cup, the surgeon tried to unscrew the handle and it would not release.After continuously trying to release the handle, the plate broke into many pieces.Fragments fell into the patient and were removed.There was a 5-minute delay and the surgery was completed successfully.

• Brand Name: MPACT IMPACTION PLATE Ø56
• Common Device Name: SURGICAL INSTRUMENT FOR HIP SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8775348
• Report Number: 3005180920-2019-00553
• Device Sequence Number: 2092027
• 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): 07/10/2019

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: 07/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 07/10/2019
• 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