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); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Subject device has been received and a service & repair evaluation/review was attempted; no service history review can be performed as part number 319.006 with lot number(s) 6957900 is a lot/batch controlled item.The manufacture date of this item is 7-jun-2012.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Device history records review was conducted.Hr review for: part #319.006 lot #6957900; release to warehouse date: 07jun2012; expiration date: na; supplier: synthes (b)(4).Review of the device history record(s) showed that there were potential issues during the manufacture of the product that would contribute to this complaint condition.Part 319.006 lot 6957900 contained nonconformance us1092257 for a thread feature on the needle component of both the 319.004 and 319.006 depth gauges which were found to be significantly undersized.Many of the depth gauge assemblies exhibited a noticeable ¿toggle¿ of the needle within the slider.Both a manual pull test and destructive testing were conducted and evaluated.Based on the evaluation of the data, as well as the intended use of the devices, there was no safety or functional concerns with the devices assembled with the out-of-specification components.The relevance of the nonconformance to the complaint condition will be determined when the product is returned for investigation.The bending strength of an external thread element would be a function of the size of the minor diameter, not the major diameter since the minor diameter represents the worst case cross section in terms of bending strength.A service & repair evaluation was performed.The investigation of the complaint articles has shown that: the customer reported the ball bearings were missing and the depth stick was broken.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.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 two 2.0/2.4 mm depth gauges are missing ball bearings and one of those depth gauges has a broken depth stick.This was discovered by sterile processing department.There was no patient involvement.This complaint involves two devices.

Manufacturer Narrative

A product development investigation was performed for the subject device part 319.006 depth gauge with lot number 6957900 was received as unrepairable from service and repair and reported to have missing ball bearings.The subject device was returned with the complaint condition stating the 6957900 depth gauge also was reported to have a broken measuring wire.This complaint condition was likely caused by over three years of consistent use and possible rough handling during surgery or sterile processing; however, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection, dhr review, and drawing review were performed as part of this investigation.This complaint is confirmed.The 319.006 depth gauge is an instrument routinely used in the 2.4mm lcp distal radius system.The devices were returned and reported to have missing ball bearings and one broken measuring wire.This condition is confirmed; the ball bearing is missing from both depth gauges and was not returned.The 6957900 depth gauge is missing the measuring wire which appears to have sheared off at the base of the depth gauge body.It is likely that over three years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.The 6957900 depth gauge was manufactured in 6/2012 and is over four years old.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.Upon review of the device history record, no nonconformances germane to the complaint condition were generated during the production of this device.Part 319.006 lot 6957900 contained nonconformance for a thread feature on the needle component of which were found to be significantly undersized.Many of the depth gauge assemblies exhibited a noticeable ¿toggle¿ of the needle within the slider.Both a manual pull test and destructive testing were conducted and evaluated during the investigation of this nonconformance.Based on the evaluation of the data, as well as the intended use of the devices, there was no safety or functional concerns with the devices assembled with the out-of-specification components.The bending strength of an external thread element would be a function of the size of the minor diameter, not the major diameter since the minor diameter represents the worst case cross section in terms of bending strength and therefore this nonconformance is not relevant to the complaint condition.A design clinical risk management (dcrm) review and/or occurrence rate calculation must be performed for all complaint parts which resulted in a classification of serious injury that were not generated from a literature article.Therefore, no dcrm calculation will be performed for this complaint.It is likely that over three years of consistent use and possible rough handling during surgery or sterile processing has led 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.

• 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: 6340676
• MDR Text Key: 67808814
• Report Number: 1719045-2017-10120
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943(10)6957900
• 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: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• 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: 6957900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2012
• 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