MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS; MISC ORTHO SURGICAL INSTR

Model Number	03.614.017
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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, the threaded holding sleeve for polyaxial screwdriver is not correctly threading into screw tulip.It is unknown if there were patient and procedure involvement.Concomitant devices reported: unk - screws (part# unknown, lot# unknown, quantity# unknown).This complaint involves one (1) device.This report is for (1) threaded holding sleeve for polyaxial screws.This is report 1 of 1 for (b)(4).

• Brand Name: THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10286137
• Report Number: 2939274-2020-03238
• Device Sequence Number: 16292725
• Product Code: LXH
• UDI-Device Identifier: 10705034714882
• UDI-Public: (01)10705034714882
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2020

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: 03.614.017
• Device Catalogue Number: 03.614.017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1