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

Catalog Number 319.006

Device Problem Break (1069)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This device was used for treatment, not diagnosis.(b)(4).Device is an instrument and is not implanted/explanted.No service history review can be performed because the lot/serial number cannot be traced.The manufacture date is unknown.The service history review is unconfirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The service and repair department found issues with various depth gauges during sterile processing.Two (2) depth gauges for 2.0mm and 2.4mm screws had bent tips, a depth gauge for the 2.7mm and small screws had a piece missing and two (2) depth gauges for the 2.0mm and 2.4mm screws had a metal piece broken off.This report is 3 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A service and repair history record review was attempted but could not be completed because the complaint device is a lot/batch controlled item.A device history record review was therefore performed for the complaint device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The date of manufacture is may 13, 2013.A service and repair evaluation completed for the complaint device.The customer reported the metal piece broke off.The repair technician reported the tip was bent and the protective cover was missing.The main cover would not slide on.¿tip broken¿ is the reason for repair.The cause of the issue is unknown.The complaint device will be forwarded to customer quality.The evaluation was confirmed.The cause of the issue is unknown.The service and repair evaluation was confirmed.The complaint device was forwarded to synthes customer quality for additional investigation.A product development investigation was also completed for the complaint device (depth gauge for 2.0mm and 2.4mm screws, part number 319.006, lot number 7378713).The device was received by synthes customer quality with the hooked needle probe broken off at the base of the black body.The broken stem is approximately 75mm in length.Drawings 319_006, (manufactured/current) for the device were reviewed.No drawing issues or discrepancies were noted.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.The thickness of the needle (1.25 mm) is driven by the fact that the needle must fit into a drilled hole of 1.5 mm, and the length (80 mm) is determined so the slider can measure screws up to 40 mm.The material of the needle probe component (part # 319.006.03) is extra hard 316ss, which is an appropriate material for an instrument component of this type.The complaint condition was confirmed; however, a root cause could not be determined.No manufacturing or design issues were noted during the investigation.The design is determined to be adequate for its intended use when used and maintained as recommended.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional clarification: although the complained instrument conditions were discovered during sterile processing, it is unknown when these issues actually occurred.It is unknown if there was patient and/or surgical involvement.There was no report of patient harm.

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5784279
• MDR Text Key: 49234699
• Report Number: 2520274-2016-13416
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• 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: 7378713
• Other Device ID Number: (01)10886982189943(10)7378713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2013
• 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