MAUDE Adverse Event Report: SYNTHES BRANDYWINE DEPTH GAUGE FOR 2.7MM & SMALL SCREWS; GAUGE,DEPTH

Catalog Number 319.04

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

It was reported that the depth gauge does not slide well.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

This device was used for treatment, not diagnosis.Device is an instrument and is not implanted / explanted.Initial reporter: phone number (b)(6).Investigation could not be completed, no conclusion could be drawn as no device was returned.Review of manufacturing records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis an evaluation was performed on the returned device.As per received condition the device measuring tip is bent, there are minor scratches on the depth gauge body, and there is a scratch running down the laser marked measurement numbers.The device is also difficult to slide.One depth gauge for 2.7mm to 4.0mm screws, up to 50mm ((b)(4)| lot # 5679869) was received with a complaint category of sticks/jams/stuck.The device is in good condition with minor scratches on its body, and one long scratch down the laser marked screw length measurement numbers, the numbers are still legible.The measuring shaft is bent 20 mm from the distal tip.When assembled, the device does not slide easily.The ball plunger and measuring shaft have a few gouges from coming in contact with something harder than bone.The interior surface of the body has wear marks from the ball sliding during use.The measuring gauge is used during orthopedic surgery involving small fragment plates and screws, and it is used to measure screw length prior to implantation of a small fragment plate.The returned device is part of the mini fragment instrument and implant set and is illustrated in technique guide.The returned device was manufactured in (b)(6) in (b)(6) of 2008.The drawing was reviewed and is determined to be suitable for the design and related dimensional conformity for this device.Technique guide provides for proper care, use, routine cleaning and inspection of instruments and should be followed.The age of the instrument and the gouges on the ball and bearing surface of the measuring shaft have contributed to this complaint.Over time, the gouges on the ball bearing have scored the interior surface of the body which caused the sticking issue.Method of use and the instrument age were the causes of this complaint and it determined not to be a design deficiency.This part is determined to be suitable for its intended use when used and maintained as recommended.Therefore, the complaint is confirmed, however the design of the device did not contribute to this complaint.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is on going; no conclusion could be drawn.The (dhr) device history report was reviewed no issues were found during manufacture that would contribute to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during an open reduction internal fixation on (b)(6) 2014, the surgeon attempted to slide the internal mechanism of the depth gauge to capture the far cortex, but it would not move easy inside the lumen of the outer piece, therefore, he would feel resistance to the sliding mechanism.There was no surgical delay, and the surgery was completed successfully with a like depth gauge.Patient condition is unknown.

• Brand Name: DEPTH GAUGE FOR 2.7MM & SMALL SCREWS
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3767893
• MDR Text Key: 4376041
• Report Number: 2530088-2014-10070
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.04
• Device Lot Number: 5679869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2008
• 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