MAUDE Adverse Event Report: SYNTHES MONUMENT DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS; GAUGE,DEPTH

Catalog Number 319.004

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Part number: 319.004, synthes lot number: 7945460: release to warehouse date: mar 13, 2015.Mfg.Site: (b)(4).No non-conformance reports 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.No service history review can be performed as part number 319.004 with lot number(s) 7945460 is a lot/batch controlled item.The manufacture date of this item is 13-mar-2015.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.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 tip of the depth gauge for 1.3mm and 1.5mm screws was discovered broken during sterile processing.No patient or procedure involvement.This is report number 1 of 1 for (b)(4).

Manufacturer Narrative

A service history evaluation/review was performed.The investigation of the complaint articles has shown that: the customer reported the tip of the depth gauge was broken.The repair technician reported that part of the tip broke off.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.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

A product development investigation was performed for the subject device.One depth gauge for 1.3/1.5mm screws (part # 319.004, lot # 7945460) was returned for investigation.The hooked needle is slightly bent but functional.The device slides as expected with no abnormal resistance.A portion of the hooked tip is sheared off and was not returned.This complaint condition appears to be the result of wear accumulated over the life of the device, but the exact cause is unknown.The returned part(s) are determined to be suitable for their intended use when used and maintained as recommended.This complaint is confirmed, but the design of the device did not contribute to this complaint.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, functional test, 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 condition is confirmed.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 1.3MM AND 1.5MM 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6046316
• MDR Text Key: 58054747
• Report Number: 1719045-2016-10769
• 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: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.004
• Device Lot Number: 7945460
• Other Device ID Number: (01)10886982189936(10)7945460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2015
• 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