MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.8MM TROCAR; GUIDE, SURGICAL, INSTRUMENT

Model Number	312.02
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 2.8 mm trocar (part # 312.02, lot # unknown) was received at us cq.Upon visual inspection, it was observed that the trocar was bent.No other issues were identified with the returned device.Dimensional inspection: dimensional analysis was not performed as the device is bent due to post-manufacturing damage.The complaint was confirmed as the device was found to be bent.No definitive root-cause can be determined based on the provided information.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.
Event or Problem Description
It was reported that on an unknown date, during a routine incoming inspection of a loaner set, it was observed that a trocar was bent.There was no known patient, or hospital involvement.This report is for one (1) 2.8mm trocar.This is report 1 of 1 for (b)(4).

• Brand Name: 2.8MM TROCAR
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10748661
• Report Number: 2939274-2020-04848
• Device Sequence Number: 14217691
• Product Code: FZX
• UDI-Device Identifier: 10886982187550
• UDI-Public: (01)10886982187550
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2020

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: 312.02
• Device Catalogue Number: 312.02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/28/2020
• Patient Sequence Number: 1