MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM TI MULTILOC SCREW LENGTH 50MM; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.019.050
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Synthes sales rep.Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on (b)(6) 2019, before the case started, the sales consultant was teaching the surgical technologist on how to load the titanium multiloc screws onto the unknown screwdriver.When this screw was unable to be loaded, the surgical technologist noted that the screw seemed to be bent out of shape.This screw was not needed during the actual case so there was no patient involvement or delay to the case.Concomitant device reported: unknown screwdriver (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: 4.5MM TI MULTILOC SCREW LENGTH 50MM
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8696736
• Report Number: 2939274-2019-58636
• Device Sequence Number: 11337446
• Product Code: HSB
• UDI-Device Identifier: 10886982089922
• UDI-Public: (01)10886982089922
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K103002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2019

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: 04.019.050
• Device Catalogue Number: 04.019.050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 06/13/2019
• Patient Sequence Number: 1