MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM; SCREW,FIXATION,BONE

Model Number	202.872
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device procode: hrs.Device is not expected to be returned for manufacturer review/investigation.Product was not returned.Device history records review could not be completed without lot number.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
It was reported that on an unknown date, one (1) cortex screw self-taping with t8 stardrive recess was missing from the received order of eight (8) cortex screws.Only one (1) device out of eight (8) devices was missing.It was shipped in a fedex express envelope and was not sealed on the side.It was supposed to be sealed on the side as part of the manufacturing process.There was no patient involvement.This report is for one (1).This is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8520503
• Report Number: 2939274-2019-57505
• Device Sequence Number: 1612226
• Product Code: HWC
• UDI-Device Identifier: 10886982145055
• UDI-Public: (01)10886982145055
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K113364
• 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): 03/22/2019

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: 202.872
• Device Catalogue Number: 202.872
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/16/2019
• Patient Sequence Number: 1