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

If the information is unknown, not available or does not apply, the section/field of the form is left blank.No known patient involvement.Date of event: 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 2 of 3 for (b)(4).

Manufacturer Narrative

Dhr review was completed.Part number: 319.006.Synthes lot number: 6142094.Release to warehouse date: 20-may-2009.Manufacturing site: synthes (b)(4).The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Non concormance was generated for component 319.006.03 for the length specification.The product was dispositioned to be used as is.This non-conformance is not relevant to the complaint condition since 03apr2009.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: device interaction/functional.Received device: depth gauge 319.006, lot 6142094.Upon receipt, it was confirmed this device was not broken, which aligned with the complaint description that two of three depth gauges were loose and falling apart, but not broken.Therefore, the investigation flow is only for device interaction/functional.Visual inspection: visual inspection by cq of the returned device revealed the depth gauge¿s needle was unthreading from the slider.None of the device¿s subcomponents were broken.The needle had a slight bend.The complaint conditions of broken and fell-apart did not agree with the received condition; the complaint conditions of broken and fell-apart were not confirmed.Functional test: the needle was found to be loose while assembled within the slider.Once assembled with the body, the depth gauge assembly had no noticeable looseness.Based on functional testing, the received condition of the device agreed with the complaint description of loose.The complaint condition of loose was confirmed.Dimensional inspection: dimensional inspection of the thread features of the slider and needle could not be performed as it would have involved destruction of the device.Dimensional inspection with caliper revealed the dimension from the ¿0¿ graduation to the flat face of the needle hook was 86.53mm, which was above specification of 84.5mm +/-0.8.Document/specification review: the following drawings were reviewed: top level depth gauge drawing; needle 3; slider.During the investigation no product design issues were observed that may have contributed to the complaint condition.Dhr review: 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.Conclusion: the complaint condition of loose was confirmed.The complaint condition of broken and fell-apart were not 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 its 9+ years of 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: 7925709
• MDR Text Key: 122463425
• Report Number: 2939274-2018-54050
• 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

• Date FDA Received: 10/02/2018
• 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: 6142094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Date Manufacturer Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1