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

Catalog Number 319.004

Device Problem Failure to Align (2522)

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

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient id, date of birth and weight are not available for reporting.Device is an instrument and is not implanted / explanted.No service history review can be performed as part number 319.004 with lot numbers 9936338 is a lot/batch controlled item.The lot/serial number cannot be traced.The manufacture date is unknown.The service history review is unconfirmed.Device history records review was completed for part # 319.004, lot # 9936338.Release to warehouse date: nov 11, 2015, made by synthes (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 device was received and the product evaluation is in progress.No conclusion can be drawn.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.

Event Description

It was reported that on (b)(6) 2016, during a distal phalanx open reduction internal fixation (orif), two depth gauges were not sliding back and forth smoothly.There was a less than one minute delay in surgery to switch depth gauges.The patient outcome was reported as stable.This report is for one (1) depth gauge for 1.3mm and 1.5mm screws.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Service and repair evaluation was completed for part # 319.004, lot # 9936338.The customer reported the depth gauge was not sliding back and forth smoothly.The repair technician reported the device did not operate smoothly, and was sticking and binding.Binding is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item was forwarded to customer quality.The evaluation was confirmed.Product investigation was completed.A visual inspection, drawing review and device history records review were performed as part of this investigation.The complaint is confirmed.The returned device slides back and forth with a small amount of friction.There are some scratches on the slider body which appear to be a result of interaction with the sleeve.The ball bearing in the slider body is depressed and cannot be depressed any further.There is some minor surface wear on the device which does not impact functionality.The (b)(4) depth gauge is intended for use in measuring for 1.3mm and 1.5mm screws in various plating systems and is listed in techniques guides for headless compression screws, the modular hand system, and the rotation correction plate system.Drawings were reviewed.The width of the slider for (b)(4) was measured to be 7.87mm which is within the specification of 7.85mm +/- 0.05.The height of the slider for 319.004 was measured to be 5.99mm which is within the specification of 6mm +0/-0.05.The inner diameter of the body for (b)(4) was measured to be 8.01mm which is within the specification of 8mm +0.05/-0.0.Measured using mitutoyo caliper.There were no issues during the manufacture of this product that would contribute to this complaint condition.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.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 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6130062
• MDR Text Key: 60992179
• Report Number: 1719045-2016-10855
• 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
• Report Date: 11/04/2016

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: 319.004
• Device Lot Number: 9936338
• Other Device ID Number: (01)10886982189936(10)9936338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 11/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2015
• 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
• Patient Age: 15 YR