MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET 1PC FLEX DRILL BIT 25; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Catalog Number 227425500

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.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.No product was returned.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Investigation methods: was patient affected: no.Device history reviewed: no.Lot trace obtained: no.Complaints database searched: yes.Product checked: no.Label checked: no.Product pulled from stock for inspection: no.The complaint states the quickset 1pc flex drill bit 25 was reported for unknown reason.A review of complaints databases identified previous complaints received for this product.However a specific search associated with the failure mode was not possible as no reason for the complaint was provided.No product was returned hence the complaint cannot be confirmed.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep (b)(4).Update - 2/21/2019 - product received.Examination of the returned complaint found the majority of the fluted tip broke off.Previous investigations have determined that use error is the likely root cause.A search of the complaint database found additional reports of drill bit breakage and bending within the 2274 drill family.The previous investigations identified the function and intended use of the drill bits is to create an initial pilot hole in which screws can be placed to affix the acetabular shell to the acetabulum.These drill bits can be either flexible or straight.During the surgical procedure, as described in the surgical technique brochure 061142-050, the drills are attached to a hand-held power drill, and using a guide drill, pilot holes are created at the required angle for proper screw placement.The drill bits are manufactured with 455-grade stainless steel.455-grade stainless steel has been approved for use in surgical procedures but not for the purpose of prolonged in vivo implantation.The pinnacle cups have screw holes for additional fixation using cancellous screws.The location and angles of these screw placements are very critical due to underlying soft tissue and nervous system damage that could result from improper screw placement.These angles can very up to 34 degrees.These variations in angles and placement could induce eccentric loads on drill bits during use and could become susceptible to failure or breakage.In addition, multiple uses under extreme eccentric loading could result in premature bending or failure of the drill bit.A health hazard evaluation (b)(4) was previously conducted.As part of the health hazard evaluation (b)(4) the fmea#(b)(4) was reviewed, and this hazard/harm was addressed by that fmea.Previous investigations found as a result of trending health hazard evaluation, (b)(4) was conducted.The investigation did not establish the need for corrective action based on no immediate patient risk, the low frequency of reported events, and suspected customer misuse as the root cause.No evidence was found of product or design error as a contributing factor.Complaints will be monitored under sep (b)(4) post market surveillance.

Event Description

The quickset 1pc flex drill bit 25 was broken.

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: examination of the returned instrument confirmed the complaint.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: QUICKSET 1PC FLEX DRILL BIT 25
• Type of Device: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8407534
• MDR Text Key: 139450665
• Report Number: 1818910-2019-86851
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10603295109129
• UDI-Public: 10603295109129
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

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: PG263561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR