MAUDE Adverse Event Report: DEPUY IRELAND 9616671 MI CALCAR REAMER SHAFT; HIP INSTRUMENTS : REAMERS

Catalog Number 257004500

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/19/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Revision due to fracture.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Product complaint # : (b)(4).Investigation summary: the instrument associated with this report was not returned.Root cause undetermined.Depuy 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.Device history lot : null.Device history batch : null.Device history review: null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.

• Brand Name: MI CALCAR REAMER SHAFT
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8160566
• MDR Text Key: 130219534
• Report Number: 1818910-2018-78084
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295143192
• UDI-Public: 10603295143192
• 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
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 257004500
• Device Lot Number: 45199748
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR