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

Catalog Number 319.006

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the service and repair department documented the depth gauge for 2.0mm and 2.4mm screws had piece snap off and the depth gauge for 2.7mm & small screws and quantity 2 of the depth gauge for small screws are bent.This device was discovered after cleaning.No patient involvement.No additional information will be made available at this time.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Service history review: lot #7039736 no service history review can be performed as this is a lot controlled item.The manufacture date of this item is 28-sep-2012.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.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: the part returned for inspection, the repair technician reported the tip was broken.The item is not repairable.The cause of the issue is undetermined.Product development evaluation details, one part # 319.006 was received in two pieces.The silver rod of the measuring device is broken off at the junction to the black graduated rod.The handle has various marks and scratches, and the laser marking on the shaft is clearly visible.The returned depth gauges show signs of regular usage, with various scratches and marks.Gauge-1, is bent in the distal hooked tip; gauge-2, lot# 7039736, has the measuring needle broken off at the interface to the black graduated rod; gauge-3 and gauge-4 are both bent at the distal hooked tip.The damage appears to be the result of damage during sterile processing.The inspection of the returned components showed no design issues.A drawing review, service & repair review, and risk assessment review were performed as part of this investigation.No product issues or discrepancies were observed.The returned instrument(s) are additional instruments used during implantations to measure screw sizes and proper use and maintenance are addressed in numerous technique guides.The returned part(s) are determined to be suitable for their intended use when used and maintained as recommended.This complaint is confirmed, however, the design of the device did not contribute to this complaint.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 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: 4264062
• MDR Text Key: 5106104
• Report Number: 3003787298-2014-10063
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• 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: 7039736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2012
• 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