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 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

Implant and explant dates: device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.No service history review can be performed as part number 319.006 with lot number(s) 7366871 is a lot/batch controlled item.The manufacture date of this item is may 07, 2013.The source of the manufacture date is the release to warehouse date.Part 319.006, lot 7366871: release to warehouse date: may 07, 2013.Manufacture location: synthes (b)(4).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 this product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 tip of a depth gauge for 2.0mm and 2.4mm screws broke during sterile processing.The device was successfully used during surgery on (b)(6) 2016.No issues with the device were reported prior to sterile processing.The device was cleaned immediately after surgery.It is unknown how the device broke however, it was confirmed that the breakage occurred during sterile processing.The tip and device will be returned for evaluation.No case or patient involvement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A service and repair evaluation was completed: the customer reported the tip of the depth gauge broke.The repair technician reported tip broken as 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

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device.The measuring hook of the returned device is broken off of the slider at the threads.The threads of the measuring hook remain in the slider.In addition, the measuring hook is bent in the middle of the part, and there are scratches on the slider handle.There are no other issues noted during investigation.A visual inspection, dimensional test, and drawing review were performed as part of this investigation.The 319.006 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.The following drawings were reviewed during investigation: depth gauge for 2.0/2.4mm screws - 319_006, needle - 319_006_3.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.The diameter of the measuring hook was measured to be 1.24mm which is within the specification of 1.25mm +0/-0.05 per 319_006_3.(measured using mitutoyo caliper.) no definitive root cause was able to be determined.The cause of the broken needle is most likely related to rough handling during sterile processing.There were no issues during the manufacture of this product that would contribute to this complaint condition.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: 6138907
• MDR Text Key: 61249894
• Report Number: 1719045-2016-10870
• 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: 11/08/2016

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: 7366871
• Other Device ID Number: (01)10886982189943(10)7366871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/19/2016; 12/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2013
• 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