MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	03.168.013
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: part #: 03.168.013; lot #: 170413-205; supplier lot #: 170413-205; release to warehouse date: may 25, 2018; supplier: (b)(4); no ncr's 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.Visual inspection: the protection sleeve for fns insertion instruments (part # 03.168.013 / lot # 170413-205) was received at us customer quality (cq).Upon visual inspection, the distal tip of the device was found to be deformed/bent outward.Additionally, there were scratches on the device which do not affect the functionality of the device.No other defects were observed with the returned device.Device failure/defect identified? yes.Dimensional inspection: specified dimensions: distal tip od.Measured dimensions: distal tip od (before bend) = conforming device used - caliper.Document/specification review: the following current and manufactured revisions were reviewed: manufactured and current revisions.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the distal tip of the device was deformed outward.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, a damaged trochar and fns fell on the floor during an unknown procedure.There was no patient involvement.This report involves one (1) protection sleeve for fns insertion instruments.This is report 2 of 2 for (b)(4).

• Brand Name: PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12393521
• Report Number: 2939274-2021-05067
• Device Sequence Number: 14633652
• Product Code: GEA
• UDI-Device Identifier: 10886982274441
• UDI-Public: (01)10886982274441
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2021

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: 03.168.013
• Device Catalogue Number: 03.168.013
• Device Lot Number: 170413-205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1