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

Catalog Number 319.006

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the depth gauge for 2.0mm and 2.4mm screws tip broke off during the case.Defect was discovered during cleaning.This is not for a warranty replacement only.This event did not contribute to a death or injury, whether the device was misused or not.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device used for treatment, not diagnosis.Device is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn.Placeholder.

Manufacturer Narrative

Additional evaluation - the returned depth gauge for 2.0mm and 2.4mm cortex screws measures up to 50mm (part number 319.006, lot number 6354123) was received for evaluation with complaint category of, broke and complaint description of the following; the service and repair department documented the tip broke off during the case.Discovery was made during cleaning.This is not for a warranty replacement only.The device did malfunction during surgery while being used on patient.The reported instance was not an anticipated service or warranty replacement issue.The depth gauge was received in two pieces.The needle was separated from the slider.The break occurred where the needle is threaded into the slider and the threaded portion of the needle remains in the slider.This failure mode occurs when a side load is applied to the needle.The thread is a m1.2 x 0.25 and does not withstand a large side load.The thread is a m1.2 x 0.25 and does not withstand a one depth gauge for 2.0mm and 2.4mm cortex screws measures up to 50mm (part number 319.006, lot number 6354123) was received for evaluation with complaint category, broke.Product drawings for depth gauge, needle, slider and screws were reviewed during this evaluation.The material specification for the needle is (b)(4).This material is typical of depth gauges sold by synthes and is acceptable for this use.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.The mechanism of failure points to a side loading condition which would be customer misuse.The design is adequate for its intended use and did not contribute to this complaint condition.This complaint is invalid from a design perspective, large side load.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a service history of the past three years has been reviewed.No service history review can be performed.The item has not previously been in for service.There is no information relevant to the current complained issue.Additional evaluation was conducted.The customer reported the tip broke off.The item is not repairable.The cause of the issue is unknown.

Manufacturer Narrative

Additional narrative: manufacturing evaluation was performed on the returned product.The returned depth gauge for 2.0mm/2.4mm screws is in used condition and the needle component is broken off where it connects with the slider component.The returned instrument is damaged and the following features are unobtainable because the features are not able to be checked without destroying the assembled components.Dimensional check on the broken needle component is unobtainable; therefore deeming this complaint determinate from a manufacturing perspective.

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
• 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 ; 8006207025
• MDR Report Key: 3625975
• MDR Text Key: 17948787
• Report Number: 3003787298-2014-00008
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2014
• 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: 6354123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1