MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. QUICKSET 1PC FLEX DRILL BIT 35; HIP INSTRUMENT/TRIAL

Catalog Number 227435500

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product associated with this reported event was not returned for examination.Requests for additional investigational inputs were made in accordance with (b)(4) appendix a.No additional information was obtained.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, (b)(4) 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 (b)(4) post market surveillance.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

While drilling to put a screw into the cup, the end of the drill bit broke and was left in the patient's bone.

• Brand Name: QUICKSET 1PC FLEX DRILL BIT 35
• Type of Device: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6258610
• MDR Text Key: 65029293
• Report Number: 1818910-2017-11084
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2017

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: 227435500
• Device Lot Number: PG243794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2017
• Initial Date FDA Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1