MAUDE Adverse Event Report: SYNTHES MONUMENT DEPTH GAUGE FOR 3.5MM CORTEX SCREWS; GAUGE,DEPTH

Catalog Number 319.091

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This device was used for treatment, not diagnosis.No patient involvement.(b)(4).Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.No ncrs were generated during production.Review of the device history records showed that 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 is reported six (6) different depth gages were damaged or not functioning.Each issue was discovered in sterile processing, no patient involvement.Two (2) depth gauges for small screws have a bent tip.One (1) depth gauge for 3.5mm cortex screws and one (1) depth gauge for locking screws to 100mm for im nails appear to be missing a ball bearing, preventing the device from remaining assembled.One (1) depth gauge for 1.3mm and 1.5mm screws will not slide and one (1) depth gauge for 2.0 and 2.4mm screws has a broken tip.This report is 3 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis a product development investigation was performed for the subject device.The returned instrument (part #319.091 / lot # 9859697) intended for measuring for 3.5mm cortex and pelvic screw as addressed in the technique guides.The depth gauge was received with the silver ball bearing and spring on the side of the slider body missing.The laser marking on the shaft is clearly visible.Thus, based on the received condition, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the ball bearing and spring were not returned.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.The returned part was determined to be suitable for its intended use when employed and maintained as recommended.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 3.5MM CORTEX SCREWS
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6011962
• MDR Text Key: 56965504
• Report Number: 1719045-2016-10741
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.091
• Device Lot Number: 9859697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2015
• 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