MAUDE Adverse Event Report: GYRUS ACMI, INC BLACK OVAL-TOP TORP,HA, PP

Model Number 140858

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, olympus followed up with the user facility to obtain additional information regarding the reported event but no information was obtained.The referenced device was returned to olympus for evaluation.A visual inspection of the received condition was performed on the device; the device was received opened in the original box and packing.The device was inspected under a microscope; foreign material noted, consistent that the device was in use.The evaluation confirmed the device was broken into two pieces.The exact cause of the reported event could not be conclusively determined.However, based on the physical evaluation, the operator's technique cannot be ruled out as a contributory factor.As a preventive measure, the instruction manual provides warning and cautions which state, as all prostheses are inherently delicate and some materials, such as hydroxylapatite, are brittle in nature, careful handling is essential to prevent damage during manipulation, trimming or sizing, and implantation/explantation.All trimming or sizing should be performed on a cutting block with only the shaft resting on the surface of the cutting block so as not to place excessive stress on the head and shaft interface.Inspect all packages for punctures or evidence of contamination prior to opening.The products will remain sterile in an undamaged, unopened package.

Event Description

Olympus was informed that during an unspecified procedure, the doctor went to implant the device into the patient, but the device broke into two pieces.The "ball" portion came off the device prior to implantation.The procedure was not completed.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information reported from the user facility.The user facility further reported that the intended procedure was completed by using another total ossicular replacement prosthesis (torp) device.The surgeon stated that it broke outside of the patient.No other information was provided.

• Brand Name: BLACK OVAL-TOP TORP,HA, PP
• Type of Device: BLACK OVAL-TOP TORP
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8587169
• MDR Text Key: 144851494
• Report Number: 2951238-2019-00809
• Device Sequence Number: 1
• Product Code: ETA
• Combination Product (y/n): N
• PMA/PMN Number: K864443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 140858
• Device Lot Number: MH694292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1