MAUDE Adverse Event Report: SYNTHES MONUMENT DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE,DEPTH

Catalog Number 319.006

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Dhr review for part#319.006 lot#7959903.Release to warehouse date: 26-mar-2015.Supplier: (b)(4).No ncrs 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.Components: dhr review for part#319.006.05 lot#7923214 (slider).Release to assembly date: 2-mar-2015.Supplier: (b)(4).No ncrs 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.Dhr review for part#es0010.02lot#7704369 (2.5 diameter ball).Release to assembly date: 30-may-2014.Supplier: (b)(4).No ncrs 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.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 is reported during routine inspection of field equipment it was noted the depth gauge sticks and will not slide well.No patient or surgical involvement.This report is for one (1) depth gauge.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product development investigation was performed on the returned subject device.One (1) depth gauge for 2.0mm and 2.4mm screws (part number 319.006 / lot number 7959903) was received.A device history record (dhr) review, device inspection, functional test, and drawing review were performed as part of this investigation.The depth gauge was received with an approximately 45 degree bend originating at the threaded portion of the needle where it assembles to the depth gauge body.Due to the bending, it is difficult to assemble and disassemble the sleeve component.The protection sleeve component was not received.The balance of the device is in functional condition.Thus, the complaint condition is confirmed, consistent with the reported condition, and can be replicated.No additional new malfunctions were observed during the course of this investigation.The returned depth gauge is used for measuring 2.0mm and 2.4mm screws in various trauma (including veterinary) plating systems.It is listed in techniques guides for the distal radius, distal ulna, elbow system, forefoot/midfoot, distal fibula, distal humerus, clavicle, rotation correction plate system and vet mini fragment system.Based on the date of manufacture the relevant drawings, reflecting the current and manufactured revision, were reviewed.Due to the damage inspection at the bend could not be performed.However, the diameter of the needle just distal to the bend was determined to be within the specification.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The exact cause of the complaint conditions cannot be determined as the handling and use of the devices are unknown.However, the received conditions are consistent with damage as a result of rough handling.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 use.There is no evidence of a manufacturing issue and no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: 6501384
• MDR Text Key: 73126526
• Report Number: 1719045-2017-10329
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943(10)7959903
• 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: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• 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: 7959903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2015
• 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