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 Problem No Patient Involvement (2645)

Event Date 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted / explanted.Service history review was attempted for part # 319.006, lot # 7604265.No service history review can be performed as part number 319.006 with lot number(s) 7604265 is a lot/batch controlled item.The manufacture date of this item is feb 27, 2014.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Device history records review was completed for part # 319.006, lot # 7604265.Release to warehouse date: feb 27, 2014, made by: (b)(4).No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.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

The service and repair department documented that on (b)(6) 2016, the entire needle broke off of the depth gauge while being reassembled.Incident did not occur during surgery.No patient involvement reported.This report is for one (1) depth gauge.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The manufacturing investigation is as follows.One depth gauge for 2.0mm and 2.4mm screws (part # 319.006, lot # 7604265) was returned for investigation.The depth gauge was reported to have a broken tip/needle, and it is confirmed since the device was received in multiple pieces.The hooked needle stem of the device is broken off at the base of the black body (the broken stem is approx.75mm in length) and was not returned.The slider is loose in the hollow body.The handle has various marks and scratches, and the laser marking on the shaft is clearly visible.The exact cause of the complaint condition cannot be determined.But the condition of the depth gauge is consistent with the result of a bending force applied to the needle portion of the depth gauge that is beyond the yield limit of the material.There is a protection sleeve to protect the needle during transport; and the outer body adds additional protection to the needle attachment point during storage.Although the exact cause cannot be determined, the most probable root cause for this complaint is excessive force exerted on the depth gauge by placing / dropping heavy instruments on top of the device during the sterilization process.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6103156
• MDR Text Key: 59908422
• Report Number: 1719045-2016-10827
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 7604265
• Other Device ID Number: (01)10886982189943(10)7604265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2014
• 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