MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM/UNI-ROM FEM INST STARTER; HIP INSTRUMENTS : DRILLS

Catalog Number 858963

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2020

Event Type  malfunction  

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 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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned instrument found the alleged complaint unconfirmed but found a different failure upon inspection of the instrument.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.

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.

• Brand Name: S-ROM/UNI-ROM FEM INST STARTER
• Type of Device: HIP INSTRUMENTS : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10705275
• MDR Text Key: 214119431
• Report Number: 1818910-2020-22839
• Device Sequence Number: 1
• Product Code: FSM
• 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: 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
• Device Operator: Health Professional
• Device Catalogue Number: 858963
• Device Lot Number: PV0191449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2020
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 11/08/2020; 11/20/2020
• Supplement Dates FDA Received: 11/20/2020; 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1