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 Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that following a procedure on (b)(6), 2022, it was discovered that the tip of the protection sleeve was damaged.The procedure has been completed with no delay and there was no patient consequence.Upon manufacturer investigation, it was determined that the device was bent.This report is for a protection sleeve for fns insertion instruments.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: reporter is a synthes employee.Part: 03.168.013 lot: 180241-301 supplier: lietner ag manufacturing site: (b)(4).Release to warehouse date: december 10, 2018 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the protection sleeve f/insertion instr was returned and received for analysis.Upon visual inspection, the edge of the distal tip was identified to be deformed.No other issues were observed with the returned device.Dimensional inspection: dimensional inspection cannot be performed due to post manufacturing damage.Document/specification review: current and manufactured revisions were reviewed.Investigation conclusion: the reported condition of the complaint device (protection sleeve f/insertion instr) is confirmed.The distal tip is deformed.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.

• 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
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13545972
• Report Number: 2939274-2022-00508
• Device Sequence Number: 14712171
• Product Code: GEA
• UDI-Device Identifier: 10886982274441
• UDI-Public: (01)10886982274441
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 180241-301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown