MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. US 1818910 QUICKSET 1PC FLEX DRILL BIT 25; HIP INSTRUMENT/TRIAL

Catalog Number 227425500

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2016

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.(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Drill tip broke within the drill guide.

Manufacturer Narrative

The product associated with this reported event was not returned for examination.A complaint database search has identified a trend for this failure within the 2274 quickset drill family.Previous investigations have determined that use error is the likely root cause.As a result of trending health hazard evaluation, dva-106292-hhe was conducted.The investigation did not establish the need for corrective action.No evidence was found of product or design error as a contributing factor.Complaints will be monitored under sep 419 post market surveillance.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: QUICKSET 1PC FLEX DRILL BIT 25
• Type of Device: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 6115993
• MDR Text Key: 60419312
• Report Number: 1818910-2016-31823
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 227425500
• Device Lot Number: PG233328
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/20/2016
• Supplement Dates Manufacturer Received: Not provided; 02/25/2020
• Supplement Dates FDA Received: 01/09/2017; 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR