MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US THIN OSTEOTOME HANDLE; HIP INSTRUMENTS : HANDLES

Catalog Number 242210000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient communication received.As verbalized,"i worked at (b)(6) in (b)(6).I have a complaint of about osteotome handle for the moreland set.So when you received my message can you call me at (b)(6)." (b)(6) was again contacted on (b)(6) 2018 and indicated that the blade would not engage upon the second use of the instrument.No surgical delay.

Manufacturer Narrative

Product complaint # pc-(b)(4).Investigation summary no device associated with this report was received for examination.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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 Description

Per hospital employee, the blade of the thin osteotome handle would not engage upon the second use of the instrument.No surgical delay.

Manufacturer Narrative

Correction to patient identifier and description of event or problem.The patient identifier was incorrectly filled out and should be blank.The event description is not a patient correspondence but was originally reported by a hospital employee.

• Brand Name: THIN OSTEOTOME HANDLE
• Type of Device: HIP INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7549522
• MDR Text Key: 109485735
• Report Number: 1818910-2018-59226
• Device Sequence Number: 1
• Product Code: HWM
• UDI-Device Identifier: 10603295123071
• UDI-Public: 10603295123071
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 242210000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1