MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC GOUGE 10MM-STANDARD & STRAIGHT; GOUGE,SURGICAL,GEN & PLASTIC SURGERY

Model Number	399.62
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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.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 that upon receipt of the order on (b)(6) 2018, it was noted that the tip of a gouge 10mm-standard & straight was broken off.There was no patient involvement.This report is for one (1) gouge 10mm-standard & straight.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Part 399.62, lot t168808: release to warehouse date: september 03, 2018.Manufacture site: (b)(4).A review of the device history records showed that there were no issues at the time of manufacturing of this device and its sub components that would contribute to the complaint condition.The raw material certificate was reviewed and the used material was according to the specification of the device.No non-conformance reports (ncrs) were generated during the production of this device.Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint a product investigation was completed: upon visual inspection on the there is a fracture on the left corner on the distal tip of the device.The fragment piece was not returned.The balance of device is in good condition.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 showed the device was conforming.A device history review, was performed for the returned instrument¿s lot number and no material review report (mrrs), non-conformance reports (ncrs) or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.A review of the current design drawing was performed; no issues were identified.Based on the available information it is not possible to determine a definitive root cause for the complaint condition.The raw material certificate was reviewed, and the used material was according to the specification of the device.A definitive root cause for the given complaint condition could not be determined from the provided information.However, rough handling during transit or during sterilization may have led to the complaint condition.During the investigation, no product design or manufacturing issues 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: GOUGE 10MM-STANDARD & STRAIGHT
• Common Device Name: GOUGE,SURGICAL,GEN & PLASTIC SURGERY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7936025
• Report Number: 2939274-2018-54172
• Device Sequence Number: 856964
• Product Code: GDH
• UDI-Device Identifier: 10886982202994
• UDI-Public: (01)10886982202994
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2018

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
• Operator of Device: Health Professional
• Device Model Number: 399.62
• Device Catalogue Number: 399.62
• Device Lot Number: T168808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1