MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLC HEX SCRDRVR SHAFT FLEX; HIP INSTRUMENTS : SCREWDRIVERS

Model Number	2274-06-000
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
The primary surgery was performed on (b)(6) 2020 via tha.Before the surgery, the hospital sterilized the screwdriver shaft and tried to open the package, the hospital staff found that some black liquid like corrosion adhered to the sterilized package of the screwdriver shaft.The hospital had backup device which was not sterilized, they sterilize the backup device and staggered time of onset of the surgery, and the patient could undergo the surgery on the day.The surgery was completed without any surgical delay.No further information is available.

• Brand Name: DLC HEX SCRDRVR SHAFT FLEX
• Common Device Name: HIP INSTRUMENTS : SCREWDRIVERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10763630
• Report Number: 1818910-2020-23680
• Device Sequence Number: 14292471
• Product Code: HXX
• UDI-Device Identifier: 10603295109044
• UDI-Public: 10603295109044
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2020

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: 2274-06-000
• Device Catalogue Number: 227406000
• Device Lot Number: AA0396D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1