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

Catalog Number 319.006

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed for part # 310.006, synthes lot # 7658912: release to warehouse date: 21-apr-2014, expiration date: na, supplier: (b)(6): no non conformance reports (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.A product development investigation was performed.One (1) depth gauge for 2.0mm and 2.4mm screws (part 319.006 / lot 7658912).A device history record (dhr) review, visual inspection, and drawing review were performed as part of this investigation.The complaint condition is confirmed.The device was received with the proximal portion of the needle broken off at the threads.This is where it connects to the calibrated body of the device.The distal portion of the needle component was returned and shows slight off axis bending along the length of the component.This is consistent with exposure to a lateral force.The balance of the device shows surface wear consistent with use which would not impair the function of the device.The protection sleeve component was not received.No new malfunctions were observed during the course of this investigation.The complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the device is already broken.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.The material of the needle component (part # 319.006.3) is stainless steel (ss)), which is an appropriate material for an instrument component of this type.The part was determined to be suitable for the intended use when employed and maintained as recommended.Dimensional inspection of the threaded portion would not be applicable due to the location of the break and the post manufacturing damage.The exact cause of the complaint condition cannot be determined as the handling and use of the device over its approximately 3 year lifespan are unknown.However, 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 component, which was not received, to protect the needle during transport and an outer body component which adds additional protection to the needle attachment point during use.During the investigation 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.

Event Description

It was reported that a patient underwent a procedure to repair a distal radius fracture on (b)(6) 2017.After the surgeon had drilled the final hole and was measuring for the correct depth, when the depth gauge was removed, the tip of the device broke off and fell into the patient.The surgeon was able to easily retrieve the fragment and implant the final screw.There was no delay in surgery reported and the patient is stable.This report is for one (1) depth gauge for 2.0mm and 2.4mm screws.This is report 1 of 1 for complaint (b)(4).

• 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: 6709987
• MDR Text Key: 79942142
• Report Number: 1719045-2017-10647
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943(10)7658912
• 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
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• 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: 7658912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2014
• 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
• Patient Age: 56 YR