MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED 4.0MM HEXAGONAL SCREWDRIVER; SCREWDRIVERS

Model Number	313.93
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported on an unknown date, that a 4.00mm hexagonal screwdriver and a (2) cannulated 4.00mm hexagonal screwdriver handles are leaking dye inside the instrument tray of the locking periarticular plating set.There is no patient involvement.This is complaint 2 of 3 for (b)(4).
Additional 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.To capture manufactured date of 4/24/2006.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.
Additional 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.Part 314.05, lot 5218327: manufacturing site: (b)(4).Release to warehouse date: april 24, 2006.No non-conformance 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.A product investigation was completed: the cannulated 4.0 mm hexagonal screwdriver was received with signs of wear on the handle and on the tip.The device is likely worn from 13+ years of usage.However, there were no signs of leakage of any substances.This is not consistent with the reported complaint condition.Therefore, the complaint is not confirmed.The relevant drawings was reviewed.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device absorbed a substance and leaked on to the instrument tray.However, since the parts have been decontaminated, there is no evidence of a leaking substance.No new malfunctions were observed during the course of 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.Manufacturer site: physical manufacturer.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: CANNULATED 4.0MM HEXAGONAL SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8699776
• Report Number: 2939274-2019-58658
• Device Sequence Number: 14022049
• Product Code: HXX
• UDI-Device Identifier: 10886982188243
• UDI-Public: (01)10886982188243
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2019

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
• Operator of Device: Health Professional
• Device Model Number: 313.93
• Device Catalogue Number: 314.05
• Device Lot Number: 5218327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 06/27/2019; 07/08/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 06/28/2019; 07/10/2019
• Patient Sequence Number: 1