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

Model Number	03.616.036
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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.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 (b)(6) 2020 during an mis matrix spinal procedure, the nurse attempted to remove the short retractor sleeve from the unknown screw because they loaded the incorrect screw size.The nurse had some difficulty removing the sleeve and the inner piece which attached the sleeve to the screw came off.There was no patient consequence.There was no surgical delay.The procedure was successfully completed.There is no further information available.Concomitant device reported: unknown screws: spine (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.This report is for one (1) tissue retractor-end.This is report 1 of 1 for (b)(4).

• Brand Name: TISSUE RETRACTOR-END
• Common Device Name: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10241246
• Report Number: 2939274-2020-03148
• Device Sequence Number: 2432574
• Product Code: GAD
• UDI-Device Identifier: 10705034716282
• UDI-Public: (01)10705034716282
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2020

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: 03.616.036
• Device Catalogue Number: 03.616.036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/07/2020
• 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 - SCREWS