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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A device history record 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 during inspection at the sterile processing department (spd) on an unknown date, two (2) depth gauges were broken and had a missing wire; the tip of the interlock screwdriver was bent; the handle of the straight ball spike was pitted, and the two (2) reduction forceps with points narrow-ratchet would not stay closed.There was no patient involvement.This report is for a depth gauge for 2.0mm and 2.4mm screws.This is report 1 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.H3, h6: part: 319.006; synthes lot: ft00419; supplier lot: ft00419; release to warehouse date: march 30, 2017; supplier: (b)(4).The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.No nonconformance reports (ncrs) were generated during production.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.Device evaluation: investigation flow: broken and visual (appearance not as expected) visual inspection: visual inspection of the returned depth gauge performed at customer quality (cq) confirmed the condition of needle breakage, which agrees with the reported complaint condition; as such the complaint is confirmed.The needle has broken off at its interface with slider body.The broken off needle portion and protection sleeve components were not returned.Dimensional inspection: inspection of the relevant feature, the needle, was unable to be completed as the subcomponent was not returned.Document/specification review: the following drawings, reflecting the current and manufactured revisions, were reviewed: needle depth gauge for 2.0/2.4mm screws during the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Material review: the design specifies the needle component to be manufactured from 316l extra hard stainless steel.During the device history record (dhr) review, no nonconformances were noted.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Conclusion a definitive root cause for the needle breaking could not be determined based on the provided information.It should be noted that the missing protection sleeve component has a primary function of protecting the needle component from damage.This complaint is confirmed, however, no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 8202602
• MDR Text Key: 131607663
• Report Number: 2939274-2018-55623
• 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: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• 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: FT00419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1