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

Model Number	312.01
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part #: 312.01, synthes lot number: 6574582, manufacturing site: (b)(4), release to warehouse date: 21-jan-2011.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.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 while attempting to tighten the trocar with the adjustable parallel wire guide, the trocar would not tighten or thread.The surgery was completed successfully with no delay.Concomitant device reported: unknown trocar (part# unknown, lot# unknown, quantity# 1).This report is for one (1) 2.8mm adjustable parallel wire guide.This is report 1 of 1 for (b)(4).

• Brand Name: 2.8MM ADJUSTABLE PARALLEL WIRE GUIDE
• 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: 10397304
• Report Number: 2939274-2020-03509
• Device Sequence Number: 17026353
• Product Code: FZX
• UDI-Device Identifier: 10886982187543
• UDI-Public: 10886982187543
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2020

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: 312.01
• Device Catalogue Number: 312.01
• Device Lot Number: 6574582
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA