MAUDE Adverse Event Report: SYNTHES MONUMENT DEPTH GAUGE FOR 3.5MM CORTEX SCREWS; GAUGE, DEPTH

Catalog Number 319.091

Device Problem Component Falling (1105)

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

Event Date 10/14/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Reporter contact number (b)(6).Device history records review for part# 319.091, synthes lot # 7890143.Release to warehouse date: jan 14, 2015, manufactured by: (b)(4).No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device 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

(b)(6) reported the following: it was reported that on (b)(6) 2016 patient underwent tibial plateau open reduction internal fixation (orif).During the procedure, while measuring for a long 3.5mm lag screw, the spring loaded ball from a depth gauge fell off.The depth gauge could still be used but there wasn't friction anymore between the inner and outer sleeves.The ball was retrieved; there were no fragments left behind.There was no reported surgical delay.The procedure was completed successfully with no patient harm.This report is for one (1) depth gauge for 3.5mm cortex screws.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device 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 not use for treatment, not diagnosis.The manufacturing evaluation results are as follows.This complaint is confirmed.The depth gauge was received with a missing the ball and spring components which provide friction between the inner and outer sleeves.Unable to determine a definitive root cause based on the complaint details.This complaint was most likely due to aggressive handling.Whether this complaint can be replicated is not applicable as the device has already fell apart due to the ball and spring being missing.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.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 3.5MM CORTEX 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: 6076567
• MDR Text Key: 59125989
• Report Number: 1719045-2016-10807
• 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: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 319.091
• Device Lot Number: 7890143
• Other Device ID Number: (01)10886982190000(10)7890143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/30/2016; 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2015
• 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