MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE,DEPTH

Catalog Number 319.006

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

No known patient involvement.Exact date is unknown.The device was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records review has been requested.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) 2018, two (2) depth gauges were found by sterile processing department (spd) to have a metal piece unscrewing and seemed to be coming apart where the wire attaches to the black body.The spd were afraid that it would not measure correctly.There was a third depth gauge that was also discovered in spd with a metal piece broken off.There was no procedure and/or patient involvement.This report is for one (1) depth gauge for 2.0mm and 2.4mm screws.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: dhr review was completed.Dhr review for part number 319.006.Synthes lot number: ft00291.Supplier lot number: ft00291.Release to warehouse date: 21-dec-2016.Manufactured by (b)(4).The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.No ncrs were generated during production review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.Us customer quality (cq) investigation flow: broken.Received device: depth gauge 319.006, lot ft00291.Visual inspection by cq of the returned device revealed the depth gauge¿s needle had broken off; the break occurred where the needle threads into the slider: the needle broke flush with the slider.A portion of the needle remained in the slider and could not be disassembled.The remaining portion of the needle was not returned.Based on visual inspection, the received condition of the device agreed with the complaint description.The complaint condition of broken was confirmed.No other damage was noted to the device.Dimensional inspection could not be performed due to the received condition of the device.The following drawings were reviewed: top level depth gauge drawing; needle.During the investigation no product design issues were observed that may have contributed to the complaint condition.Device history record(s) showed that there were no issues during the manufacture of this product including the materials and its properties, which would contribute to this complaint condition.The complaint condition was confirmed.There were no issues during the manufacture of this product, including its material properties, that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.While no definitive root cause could be determined it is possible that the device experienced abnormal or excessive forces during handling/use.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7925700
• MDR Text Key: 122476157
• Report Number: 2939274-2018-54051
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

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: Health Professional
• Device Catalogue Number: 319.006
• Device Lot Number: FT00291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/02/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1