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

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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
• Type of Device: ADDITIONAL PRODUCT CODES: HRS, JDS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7324203
• MDR Text Key: 102079924
• Report Number: 2939274-2018-50929
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982215895
• UDI-Public: (01)10886982215895(10)LOTUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 422.395
• Device Catalogue Number: 422.395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1