MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TISSUE RETRACTOR-END/LONG

Model Number	03.616.038
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and/or 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.Without a lot number the device history records review could not be completed.Product was not returned.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 synthes reports an event in (b)(6) as follows: it was reported on an unknown date that performing a matrix mis time the nurse was having difficulties to loading a screw onto the retractor tissue (long).Also, during the final tightening of the handle torque limiting was making a weird noise and surgeon requested to replace the handle.The patient was not impacted by this and the procedure was successfully completed.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity unknown).This is report 1 of 1 for 1 (b)(4).

• Brand Name: TISSUE RETRACTOR-END/LONG
• Common Device Name: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9312046
• Report Number: 2939274-2019-62127
• Device Sequence Number: 16283768
• Product Code: GAD
• UDI-Device Identifier: 10705034716305
• UDI-Public: (01)10705034716305
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/24/2019

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: 03.616.038
• Device Catalogue Number: 03.616.038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1