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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.(b)(4).Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.No service history review can be performed as part number 319.006 with lot number(s) 7038736 is a lot/batch controlled item.The service history review is unconfirmed.(dhr) review device history records review was requested.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided.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 the tips of two depth gauges broke off during surgery on an unknown date.It is unknown the type of surgery and or the exact way the tips broke off.There was no information available about the surgery or patient outcome.It is unknown if the tips were retrieved form the patient or not.Device is available for return.This report involves 2 device.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Service history review was performed on part number: 319.006, lot number: 7039736: no service history review can be performed as part number 319.006 with lot number(s) 7039736 is a lot/batch controlled item.The service history review is unconfirmed.A device history record (dhr) review was performed for part # 319.006, lot # 7039736, release to warehouse date: 28-sep-2012, manufactured by: (b)(4); 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 products, and any subcomponents, which would contribute to this complaint condition.A product investigation was performed.The following part(s) were returned: 319.006, lot ft00291, mfg: 21-dec-2016, qty: (b)(4), lot: 7039736, mfg: 28-sep-2012, qty (b)(4).The complaint condition is confirmed as the device(s) were received with the proximal portion of the needle broken off at the threads.The distal portion of the needle component was not returned.This is where it connects to the calibrated body of the device.The balance of the device shows surface wear consistent with use which would not impair the function of the device.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(s) of manufacture the relevant drawings, reflecting the current and manufactured revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The material of the needle component (part # 319.006.3) is (b)(4)), which is an appropriate material for an instrument component of this type.Dimensional inspection is not possible as the needle component was not returned.The exact cause of the complaint condition cannot be determined as the handling and use of the device over its 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 to protect the needle during transport and an outer body component which adds additional protection to the needle attachment point during use.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 returned to manufacturer.Service and repair evaluation conducted: the customer reported the tip of the depth gauge broke off.The repair technician reported the gauge tip was broken off and missing and the gauge tip guard 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 item will be forwarded to customer quality.The evaluation was confirmed.A review of the service history records have been requested and is currently pending completion.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: 6955389
• MDR Text Key: 90434069
• Report Number: 1719045-2017-11078
• 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: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• 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: 7039736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2012
• 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