MAUDE Adverse Event Report: SYNTHES BRANDYWINE ACF DETACHABLE TRIAL SPACER PARALLEL 8MM; TEMPLATE

Catalog Number 396.914

Device Problem Separation Failure (2547)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that a trial spacer handle and detachable trial spacer malfunctioned.During a demonstration between technicians, the detachable trial spacer would not detach from the trial spacer handle shaft.There was no reported patient or procedure involvement.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.The device history record was reviewed and no issues were found during manufacture that would contribute to the complaint condition.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

A product evaluation was performed.The investigation of the complaint articles has shown that :the spacer handle connects with parallel, convex and lordotic acf detachable trial spacers to assess appropriate implant size for anterior fusion of the cervical spine (technique guide j2509-f).Non-detachable trial spacers could also be used to determine the best implant size (part#s 396.405-396.422).A tolerance analysis was performed for the following features: 1) the clearance between the diameter of the inner threaded shaft and the handle inner diameter near the functional end.2) the clearance needed for the dowel pin in the wheel to freely glide within the groove to allow the assembly/disassembly of the wheel and inner shaft.After reviewing the tolerances, there is the possibility of interference for both of the features/functions stated above.The interference within the wheel assembly and the interference between the inner diameter and threaded inner shaft can lead to the scenario of this complaint.It should be noted that the lot corresponding to this complaint was of a previous revision h which had more potential interference per the drawing specifications than the latest rev j.However, there is still interference created at mmc when incorporating the straightness tolerances on the latest design.In addition to the tolerances, the depth of the pin and the spring ball plunger are not indicated on the upper level of the wheel drawing.This can also lead to the interference conducive to preventing the rotation of the wheel for disassembly.The materials were reviewed are adequate for the device's intended function.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: ACF DETACHABLE TRIAL SPACER PARALLEL 8MM
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3872773
• MDR Text Key: 4506210
• Report Number: 2530088-2014-10161
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2014

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: 396.914
• Device Lot Number: 5182929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2014
• Initial Date FDA Received: 06/13/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/17/2014; 09/19/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2006
• 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