MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S/C TRIAL HANDLE ANGLED; HIP INSTRUMENTS : HANDLES

Model Number 2055-13-000

Device Problems Defective Device (2588); Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Physician reported that product can`t be clean properly cause of the product design.The problem with this specific device was noticed by sterilization ward.The workers of the sterilization ward cleaned a nd done all sterilization procedures according to the manual and all sterilization procedures and they noticed that after some time (a couple of hours) there were some leaks on the paper.

Manufacturer Narrative

: product complaint # (b)(4).Investigation summary
=
> root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint was received which states physician reported that product can`t be clean properly cause of the product design.Additional information was received in (b)(4) which states: the problem with this specific device was noticed by sterilization ward.The workers of the sterilization ward cleaned and done all sterilization procedures according to the manual and all sterilization procedures and they noticed that after some time (a couple of hours) there were some leaks on the paper.Requests were made to obtain information regarding the exact cleaning method and detergents used and device return.No information or products were returned.It should be noted microsurgical instruments should be cleaned separate from other instruments.Disassemble instruments, as appropriate and inspect for damage.Cracked or bent instruments should be set aside and sent for service or repair.Prepare an enzymatic cleaning solution per the manufacturer¿s instructions.Soak soiled instrument for 5 minutes.Use a soft bristle brush to remove all traces of blood and debris, paying close attention to threads, crevices, seams, and any hard to reach areas.If the instrument has sliding mechanisms or hinged joints, actuate the area to free any trapped blood and debris.If the instrument is cannulated, insert a soft nylon brush, or pipe cleaner, to remove debris from cannula.Rinse the instrument thoroughly with warm tap water.Rinse all lumens, internal areas, sliding mechanisms, and hinged joints, actuating sliding mechanisms and hinged joints while rinsing.Ultrasonically clean instrument for 10 minutes in neutral ph detergent, prepared in accordance with the manufacturer¿s instructions.Rinse the instrument thoroughly with warm tap water.Rinse all lumens, internal areas, sliding mechanisms, and hinged joints.Actuate sliding mechanisms and hinged joints while rinsing.Dry immediately after final rinse.Dry internal areas with filtered compressed air, if available.Lubricate moving parts with a water-soluble lubricant, if applicable.Inspect all instruments prior to sterilization or storage to ensure instruments are suitable for use.Re-assemble instrument (if applicable), prior to sterilization, in accordance with the disassembly/re-assembly instructions provided with the instrument.In addition: when recommended, steam (moist heat) sterilization shall be performed in a locally approved, pre-vacuum (forced air removal) cycle.The steam sterilizer should be validated to the requirements of any local standards and guidance such as en 285 or aami/ansi st8.The steam sterilizer should be installed and maintained in compliance to manufacturer¿s instructions and local requirements.Ensure that the steam sterilizer cycle is chosen that is designed to remove air from porous or lumened device loads in accordance to manufacturer¿s instructions and does not exceed the criteria for sterilizer load.Examples of steam sterilization cycles that have been validated are provided in the instructions for use as guidance.It should be noted that a gap assessment has been performed for (b)(4), and the new harmonised ifu received (b)(6) 2019, versus iso17664-1 2017.The ifu¿s meet the requirements of the iso standard and it is likely that the reprocessing facility is not following the prescribed ifu.Further specifics are required from the hospital to determine whether the method they follow is as prescribed in the ifu.A complaints search identified similar complaints received previously.It was identified that on (b)(6) 2014, (b)(4), was held regarding the cleanability of the unipolar/bipolar trial inserters 205512000 (straight) and 205513000 (bent) and found no patient risk.A third party laboratory tested the parts with hemoglobin based test soils and the standard cleaning process as detailed in the ifu.The parts passed the cleaning test.Based on the preliminary risk assessment (b)(4), which did not identify a product problem or patient harm, corrective action is not indicated.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per (b)(6).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: S/C TRIAL HANDLE ANGLED
• Type of Device: HIP INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9106317
• MDR Text Key: 159765718
• Report Number: 1818910-2019-105817
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295084488
• UDI-Public: 10603295084488
• Combination Product (y/n): N
• 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: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2055-13-000
• Device Catalogue Number: 205513000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1