MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 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 12/14/2016

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.Udi: (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 bit broke inside pelvis and could not be retrieved.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

(b)(4).Examination of the returned drill confirmed the complaint; the majority of the fluted tip broke off.Review of the provided intra-op x-ray confirmed the broken piece is in the patient.A complaint database search has identified a trend for this failure within the (b)(4) 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 sep (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.

• Brand Name: QUICKSET 1PC FLEX DRILL BIT 35
• Type of Device: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6186105
• MDR Text Key: 62754619
• Report Number: 1818910-2016-33647
• Device Sequence Number: 1
• Product Code: HTW
• 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,Followup,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• 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: PG243835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2014
• 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
• Patient Age: 78 YR