MAUDE Adverse Event Report: SYNTHES BRANDYWINE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE, DEPTH

Catalog Number 319.006

Device Problems Fitting Problem (2183); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient involvement reported.Unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Device history records review was conducted.The report indicates that the: dhr review for part# 319.006 lot# 4060383, release to warehouse date: 28-jan-2000, expiration date: n/a, manufactured by synthes (b)(4).No ncrs were generated during production.Review of the device history record(s) showed there were no issues during the manufacture of this product that would contribute to this complaint condition.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 depth gauge does not slide in and out easily.This was discovered during a routing inspection.There is no case or patient involvement.There is 1 device in this complaint.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device is not expected to be returned for manufacturer review/investigation.No service history review can be performed as part number 319.006 with lot number(s) 4060383 is a lot/batch controlled item.The manufacture date of this item is 28-jan-2000.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.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.

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
• Type of Device: GAUGE, DEPTH
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5949415
• MDR Text Key: 54674846
• Report Number: 2530088-2016-10241
• Device Sequence Number: 1
• Product Code: HTJ
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/26/2016

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: 319.006
• Device Lot Number: 4060383
• Other Device ID Number: (01)10886982189943(10)4060383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 09/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2000
• 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