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

Model Number 319.006

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Lot number is unknown.: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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, the representative in the sterile processing department notified that a depth gauge was received to them broken from surgery.The skinny part of a delicate depth gauge broke off.It is speculated that equipment broke during the cleaning process.There was no patient involvement.This complaint involves one (1) device.This report is for one (1) depth gauge for 2.0mm and 2.4mm screws.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.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.

Manufacturer Narrative

Product complaint # (b)(4).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, h4, h6: a review of the device history record.Device history lot part # 319.006, synthes lot # h299834, supplier lot # h299834, release to warehouse date: 08 aug 2017, supplier: (b)(4).No ncr's were generated during production.Device history batch null, device history review review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.H3, h6: investigation summary background: it was reported that on an unknown date, the representative in the sterile processing department notified the sales consultant that a depth gauge was received to them broken from surgery.The skinny part of a delicate depth gauge broke off.Sales consultant was in the surgery where the equipment was just recently used and did not witness any broken hardware, neither did the surgeon or staff.It could only speculate that it broke during the cleaning process.There was no patient involvement.This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the depth gauge for 2.0mm and 2.4mm screws (part # 319.006 / lot # h299834) was received at us cq.The device was returned with the needle of the device broken off the body of the device.The threaded portion of the needle remained secured to the body.The protection sleeve of the depth gauge was not returned thus it will be treated as a missing component.The received condition was consistent with the complaint condition thus the complaint was confirmed.Device failure/defect identified: needle of device was broken and the protection sleeve was not returned.Conclusion: the overall complaint was confirmed for the received depth gauge for 2.0mm and 2.4mm screws as the needle was broken off the main body of the device.Although no definitive root-cause can be determined, it is possible the device experienced unintended forces during sterilization or material handling.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 9417249
• MDR Text Key: 194319698
• Report Number: 2939274-2019-62517
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Public: (01)10886982189943HTJ
• 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,Followup
• Report Date: 11/14/2019

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 Model Number: 319.006
• Device Catalogue Number: 319.006
• Device Lot Number: H299834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 12/06/2019; 01/03/2020
• Supplement Dates FDA Received: 12/31/2019; 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1