MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE

Catalog Number 323.034

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Hospital reporter title: materials manager the investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the threaded drill guide is stripped and is not threading into the plate hole.The sterile processing department (spd) was notified by an operating room (or) staff member.No patient involvement was reported.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Concomitant device reported: plate (part # unknown, lot # unknown, quantity 1).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Corrected data: manufacturer name, city and state.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product development investigation was completed.The returned device was examined and the distal threaded tip was found to be stripped.The complaint condition was unable to be replicated due to post-manufacturing damage.The 1.5mm threaded drill guide with depth gauge (323.034) is part of the modular mini fragment lcp system.The drill guide can be used to guide a drill bit through a plate and can be used to determine screw length required for insertion.Proper use and maintenance for the device(s) are addressed in technique guide for the modular mini fragment set.Three different drill guides are included in the set.Each is designed to be used with the corresponding 2.0mm, 2.4mm, or 2.7mm plate.The returned drill guide is only designed to be used with the 2.0mm plates in the lcp modular mini fragment set.Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture).The design, materials and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis is possible due to post-manufacturing damage.A device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number.Device history records review was completed for part# 323.034, lot# 7507548.Manufacturing location: (b)(4), manufacturing date: jul 07, 2011.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No definitive root cause was able to be determined.However, this failure mode is typically associated with attempted off-axis use of the guide leading to thread deformation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE
• Type of Device: GUIDE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7080061
• MDR Text Key: 93758346
• Report Number: 8030965-2017-50263
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 10886982190604
• UDI-Public: (01)10886982190604(10)7507548
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 323.034
• Device Lot Number: 7507548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2011
• 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