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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

It is unknown if there was patient involvement.Device is an instrument and is not implanted/explanted.No service history review can be performed as part number 319.006 with lot number(s) 7023970 is a lot/batch controlled item.The manufacture date of this item is august 29, 2012.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Device history record review for part 319.006, supplier synthes lot 7023970: release to warehouse date: august 29, 2013.Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Event Description

It was reported the jaws of the rod cutter shattered during use, the depth gauge tip broke, and the handle of the hammer broke.It is unknown if the three reported events occurred during the same surgery.The reported devices were set aside in the sterile processing room after sterilization with a note indicating the malfunction.The date of surgery, type of surgery, age of device, surgical delay, patient and procedure outcome remain unknown.Furthermore, the reporter could not confirm if any fragments were generated and if any fragments fell into or remain in the patient.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

The customer reported the tip broke.The repair technician reported the tip broke off the measuring device, and the protective 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 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

The manufacturer investigation results are as follows.The complaint is confirmed for the part.Upon visual inspection it can be seen that the depth gauge is missing its stem.The balance of the device was in fair condition with signs of wear and tear.The complaint condition is confirmed.A visual inspection, complaint history review, drawing review, and service and repair (s&r) review (was performed as part of this investigation.The returned part was determined to be suitable for their intended use when employed and maintained as recommended.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 dsus/trm/0515/0599.No definitive root cause was able to be determined however, 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.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: 6132770
• MDR Text Key: 61087974
• Report Number: 1719045-2016-10862
• 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,Followup
• Report Date: 11/03/2016

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: 7023970
• Other Device ID Number: (01)10886982189943(10)7023970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/21/2016; 12/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2012
• 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