MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ELITE IMPL TR HD 26MM +0; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number	2522-26-002
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The primary surgery was performed on (b)(6) 2020 via tha.Before the surgery, the hospital staff sterilized the devices by cleaning and drying with a machine.It was reported that after sterilization, the staff set out the devices for the surgery, and he/she found that water remained in the 9 trial heads when he/she pulled out the devices from the case.He/she had checked that there was no water in the trial heads when set them in the drying machine.The staff judged poor sterilization because water was remained in the devices despite sterilized by autoclave, and he/she sterilized the devices again.Preventing a recurrence of water¿s remaining, the trial heads were sterilized into small groups.The remaining of water was found at the last minute of the surgery, but barely made using in the surgery.The surgery was completed without any surgical delay.There was no harm to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the instrument associated with this report was not returned.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: ELITE IMPL TR HD 26MM +0
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10472916
• Report Number: 1818910-2020-19098
• Device Sequence Number: 2345117
• Product Code: HWT
• UDI-Device Identifier: 10603295128564
• UDI-Public: 10603295128564
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2020

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 Model Number: 2522-26-002
• Device Catalogue Number: 252226002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 08/25/2020; 11/19/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 09/15/2020; 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1