MAUDE Adverse Event Report: GYRUS ACMI, INC PLS PIST W ARM-STYLE LP

Model Number 140764

Device Problem Break (1069)

Patient Problem Hearing Loss (1882)

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The cause of the reported event cannot be determined.However, if additional information regarding the reported event becomes available, this report will be supplemented accordingly.

Event Description

During 2016, a lawsuit was filed in (b)(6) against a hospital and two ent specialists, in which the plaintiff claimed that following an ear implant procedure, the said product was broken and thus caused irreparable injury (permanent hearing loss).

Manufacturer Narrative

The reported lawsuit was in connection to an event which occurred during 2009-2010.Medtechnica (supplier) was not a defendant in said case nor received any notice following the event.Moreover, medtechnica ceased any activity in relation to the referenced product a few years ago and none of it's current personnel was involved or has knowledge of the reported event.Medtechnica has no further information regarding the reported events.

Manufacturer Narrative

There referenced device was not returned for an evaluation.Therefore the cause of the reported event remains unknown.In addition, no serial/lot numbers could be provided so a dhr review could not be conducted.A complaint history review of the device for the past 10 years was conducted and found four complaints were found including this one.The other three complaints were related to device damage prior to the procedure and had no patient involvement.There were no previous complaints were found related to broken device during/after procedure for the referenced device.A review of the instructions for use (ifu) provide the following precautions-intraoperative for ossicular replacement prostheses: "to avoid postoperative sensorineural deafness, it is important not to traumatize the inner ear or to remove perilymph from the vestibule." "the length of the prosthesis should be carefully assessed so that prosthesis doe not sit too deeply in the oval window niche because this may cause vertigo and/or loss in inner ear function." " all prostheses are inherently delicate and some materials 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." this product is designated for single use only: "reprocessing may lead to changes in material characteristics such as metallic corrosion and dulled edges, ceramic and plastic deformation or splitting which may impact the strength of the device and compromise device performance.".

• Brand Name: PLS PIST W ARM-STYLE LP
• Type of Device: PLS PIST W ARM-STYLE LP
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9265736
• MDR Text Key: 164595247
• Report Number: 2951238-2019-01174
• Device Sequence Number: 1
• Product Code: ETA
• Combination Product (y/n): N
• PMA/PMN Number: K760433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 140764
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability