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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

It is unknown if there was patient involvement.No patient information was provided.It is unknown when device broke.Lot number is unknown.Device is an instrument and is not implanted/explanted.Reporter email address is unknown.Reporter is a synthes sales consultant.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 an unknown date, two depth gauges were broken.It is unknown if there was a procedure or patient involvement.This report is for a depth gauge for 2.0mm and 2.4mm screws.This is report 1 of 2 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.H3, h6: a product investigation was conducted.The instrument was received with the reported condition of ¿broken (2+ pieces)pre or post operatively/step unknown: rm.The following investigation flow was performed: broken: it was visually observed that the needle portion has sheared off from the handle of the instrument towards the proximal end of the needle.Please note only the needle portion was returned; the handle, protection sleeve and slider were not returned.The complaint condition is confirmed and the received condition agrees with the complaint description.The cause of the issue could not be definitively traced to use error, misuse/abuse, non-compliance, postoperative trauma.Dimensional inspection was conducted per relevant drawings.Diameter of needle shaft was measured and is conforming.A device history review, could not be performed as the lot number is unknown due to the missing components.A review of the current design drawing was performed: based on the available information it is not possible to determine a definitive root cause for the complaint condition.A material/hardness review was not able to be performed as a dhr review could not be done due to unknown lot number.The complaint condition is confirmed as the depth gauge (part: 319.006) was received broken.While no definitive root cause could be determined it is possible that the device encountered unintended forces (such as being bent or damaged during sterile processing).During the investigation, no product design or manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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: 7851763
• MDR Text Key: 119495965
• Report Number: 2939274-2018-53649
• 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
• Type of Report: Initial,Followup
• Report Date: 08/20/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/06/2018
• Supplement Dates Manufacturer Received: 10/10/2018
• Supplement Dates FDA Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1