MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW SELF-DRILLING 65MM; ADDITIONAL PRODUCT CODES: HRS, JDS

Model Number	422.395
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: no patient involvement was reported.(b)(4), lot number unknown.Device was neither implanted or explanted.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 there were multiple missing screws in an evaluations set.Set was never used or sterilized.Trays never entered operating room suite.Missing screws in trays were discovered when tote was opened to check condition of trays.There was no patient involvement.This report is for one (1) 5.0mm locking screw.(b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW SELF-DRILLING 65MM
• Common Device Name: ADDITIONAL PRODUCT CODES: HRS, JDS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7324203
• Report Number: 2939274-2018-50929
• Device Sequence Number: 18869885
• Product Code: HWC
• UDI-Device Identifier: 10886982215895
• UDI-Public: (01)10886982215895(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K963325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2018

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: 422.395
• Device Catalogue Number: 422.395
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1