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

Catalog Number 319.006

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported by the operating room personnel that the device is not sliding very well, it is sticking.This event did not contribute to a death or injury, the device did not malfunction during surgery while being used on patient.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.No service history review can be performed as this is a lot controlled item.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: a service and repair evaluation was completed: the customer reported the item is not sliding well and is sticking.The repair technician stated that the wrong cover has been put on the device.The item is not repairable.The cause of the issue is unknown.This item was forwarded to the complaint handling unit for further investigation.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

Additional 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.

Manufacturer Narrative

Additional narrative: a product investigation was completed: the returned depth gauge part# 319.006 (lot# 6502208) was manufactured on october, 2010 and is approximately four years old.The depth gauge was received assembled together.The slide mechanism on the depth gauge was tested and there are no signs of the depth gauge sticking or jamming during sliding.The needle is not damaged and the tip is not broken off.The device was returned with the incorrect sleeve attached to it.This does not affect the functionality of the device.The balance of the device is in excellent condition.The design is adequate for its intended use and did not contribute to this complaint condition.Therefore, this complaint is unconfirmed from a complaint category.A review of the design drawing indicates that the returned part was manufactured to the relevant drawing.There were no changes made to the design of the device.The complaint is unconfirmed for the complaint condition, and the design is adequate for its intended use and did not contribute to this complaint condition.There is no product failure/problem identified with the returned device.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 AND 2.4 MM SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES JENNERSVILLE; 108 willowbrook lane; west chester PA 19382
• Manufacturer (Section G): SYNTHES JENNERSVILLE; 108 willowbrook lane; west chester PA 19382
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3805088
• MDR Text Key: 4364645
• Report Number: 3003787298-2014-10016
• Device Sequence Number: 1
• Product Code: HTJ
• 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,Followup
• Report Date: 04/14/2014

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: 319.006
• Device Lot Number: 6502208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2014
• Initial Date FDA Received: 05/12/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/11/2014; 07/09/2014; 11/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2010
• 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