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 Type  malfunction  

Manufacturer Narrative

No reported patient or surgical involvement.Device is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Service history review: no service history review can be performed as part 319.006 with lot 7971080 is a lot/batch controlled item.The manufacture date of this item is april 8, 2015, which is the release to warehouse date.The service history review is unconfirmed.Device history record review: manufacturing location: (b)(4) - manufacturing date: april 8, 2015.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 that a metal depth probe component has broken off of a depth gauge instrument.The issue was discovered during sterile processing as the device was dismantled for cleaning.There was no reported patient or procedural involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

An investigation summary was performed: the investigation of the complained this particular depth gauge is part of at least 14 technique guides, including the 2.4 mm variable angle lcp distal radius system and is used to measure the depth of the holes for the 2.0mm/2.4mm screws to ensure the correct screw length is used during the procedure.The information is provided per the 2.4 mm variable angle lcp distal radius system technique guide.Unable to determine a definitive root cause.However, the complaint condition was most likely caused by rough handling during sterilization.It is not likely that the design of the device contributed to this complaint.Service and repair evaluation: the customer reported the metal tip broke off the depth gauge.The repair technician reported the tip broke off, and the slide sleeve was missing.Tip broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.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.

• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5925328
• MDR Text Key: 53906897
• Report Number: 1719045-2016-10663
• 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: 08/19/2016

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: 7971080
• Other Device ID Number: (01)10886982189943(10)7971080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2016
• Initial Date FDA Received: 09/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2015
• 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