MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ZT TRIAL SLEEVE 16F LRG; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number	257616125
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device was reviewed by depuy engineering (b)(6) in a-3008080 which states my assessment is that this complaint is due to wear and tear.Root cause attributed to the device being worn from normal use and servicing.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
Items have been flagged during the sterilization process.No further information provided.Items have been handed in at our warehouse/loan kit department.

• Brand Name: ZT TRIAL SLEEVE 16F LRG
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9226433
• Report Number: 1818910-2019-111528
• Device Sequence Number: 19316549
• Product Code: LXH
• UDI-Device Identifier: 10603295146476
• UDI-Public: 10603295146476
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 10/04/2019

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: 257616125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1