MAUDE Adverse Event Report: SYNTHES BRANDYWINE 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

There was no reported patient involvement.Event date: unknown.Implant and explant dates: 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) 5180733 is a lot/batch controlled item.The manufacture date of this item is february 28, 2006.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Part 319.006, lot 5180733: release to warehouse date: february 28, 2006.Manufactured by synthes (b)(4).Review of the device history record(s) showed that there are potential issues during the manufacture of the product that would contribute to this complaint condition.A non-conformance report was created on for potential undersize diameter of subcomponents made.Relevance to complaint condition cannot be determined until the product is returned for investigation.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 a depth gauge was discovered broken by a sterile processing hospital employee.There was no record of the set which contained this depth gauge being used; there was no known procedure or patient involvement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The service evaluation results as follows.The customer reported the depth gauge was broken.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 evaluation was confirmed.The manufacturing investigation results are as follows.One depth gauge for 2.0mm and 2.4mm screws (part # 319.006, lot # 5180733) 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 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 BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6109794
• MDR Text Key: 60243102
• Report Number: 2530088-2016-10316
• 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: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• 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: 5180733
• Other Device ID Number: (01)10886982189943(10)5180733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2006
• 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