MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS CASE COMPLETE; HIP INSTRUMENTS : INSTRUMENT CASES

Catalog Number	201206300
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the cases were returned and residue confirmed on the trays.Root cause attributed to user error.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.
Event or Problem Description
Customer has been using the trilock trays for about 3 months.Now this issue is occuring: the trays have been washed about 7 times up to now and after the sterilization there is a kind of "chalk dust" on the trays.This happens only when washing the trilock trays, all other trays behave normally.The cause is unknown but the "chalk-like layer" is located on the inside and outside of the entire tray.The fear is that particles of this layer are on the instruments and can come in contact with the patient.No surgery delay, no adverse consequences for patient reported.

• Brand Name: TRI-LOCK BPS CASE COMPLETE
• Common Device Name: HIP INSTRUMENTS : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8592234
• Report Number: 1818910-2019-92894
• Device Sequence Number: 2074439
• Product Code: FSM
• UDI-Device Identifier: 10603295082323
• UDI-Public: 10603295082323
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/08/2019

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 Catalogue Number: 201206300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1