MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 12MM; SCREW, FIXATION, BONE

Model Number	212.812
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: hrs.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is an orthopedics coordinator.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that during an unknown procedure on (b)(6) 2019, a mini frag set was discovered of having a 12mm 2.4mm cortex screws in the slots where 12mm 2.4mm locking screws should be.It was mentioned that the surgeon wanted a 12mm locking screws but had to use something else to successfully complete the procedure.There was no surgical delay reported.Patient condition was unknown.Concomitant device reported: unknown cortex screws (part# unknown, lot# unknown, quantity unknown) this report is for one (1) 2.4mm locking screw slf-tpng with stardrive recess 12mm this is report 2 of 3 for (b)(4).

• Brand Name: 2.4MM LOCKING SCREW SLF-TPNG WITH 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: 9153288
• Report Number: 2939274-2019-61124
• Device Sequence Number: 19594794
• Product Code: HWC
• UDI-Device Identifier: 10886982152824
• UDI-Public: (01)10886982152824
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K103243
• 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): 09/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 212.812
• Device Catalogue Number: 212.812
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2019
• Initial Report FDA Received Date: 10/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention