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

Catalog Number 319.006

Device Problems Material Fragmentation (1261); Component Missing (2306); Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be completed.Service and repair evaluation: the customer reported the measuring needle broke off at the main body.The repair technician reported the ball bearing was missing, the handle was worn, and the tip was broken off.Tip broken is the reason for repair; however, the item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality for further evaluation.Service history record review: no service history review can be performed as part 319.006 with lot 6579007 is a lot/batch controlled item.The manufacture date of this item is january 26, 2011.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Device history record review: manufacturing location: (b)(4) instruments - manufacturing date: january 26, 2011.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device 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.

Event Description

It was reported via the service and repair department that a facility identified the following issues with seven (7) synthes parts: the measuring needles broke off from the main body of two (2) pair of depth gauges; the tip of a cannulated 4.0mm hexagonal screwdriver was stripped; the wooden handle of a stardrive screwdriver t15 broke; the notch on the end of an open end wrench broke; and two (2) combination t-wrenches were either over-torqued or stripped.There was no reported patient or surgical involvement with any of the identified issues.All of the reported device issues were assessed for reportability.Only the four (4) broken devices were deemed reportable.This report is 1 of 4 for (b)(4).

Manufacturer Narrative

Device 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.

Event Description

Correction: the mentioned open end wrench should have been reported as a guide shaft.

Manufacturer Narrative

On may 17, 2016 it was noted that the device has been received by the manufacturer on may 06, 2016.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

A product investigation was completed: during the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, functional test, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.The complaint was able to be confirmed.Although the definitive root cause could not be determined based on the given information, it is likely that the age of the device as well as excessive force contributed to the complaint condition.The complaint condition was able to be confirmed at customer quality as the two (2) depth gauges were returned with the needle broken off from the slider and the ball bearing on the handle of lot 6579007 was missing.Only one needle and protection sleeve were returned so it is uncertain as to which depth gauge the two components belonged to.Although the damage appears to be the result of excessive weight being placed onto the needle during sterile processing, the root cause cannot be definitively determined as the specific conditions at the time of the damage are unknown.The balance of the device is in fair condition with minimum signs of wear and tear.The returned part was determined to be suitable for the intended use when employed and maintained as recommended and the risk assessment was found to adequately address the complaint condition.A review of the current design drawing / manufactured revision for the top level assembly and the needle component was performed.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 is extra hard 316ss, which is an appropriate material for an instrument component of this type.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the complaint condition.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 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: 5655582
• MDR Text Key: 45200822
• Report Number: 1719045-2016-10394
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• 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: 6579007
• Other Device ID Number: (01)10886982189943(10)6579007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2011
• 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