MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 45MM; NAIL, FIXATION, BONE

Model Number	212.119
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(b)(4).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, a locking screw appeared to be broken.A follow up x-ray then revealed that the screw had come off of the unknown pediatric hip plate.It is unknown if revision surgery has been planned.Concomitant device: pediatric hip plate (part: unknown, lot: unknown, quantity: 1).This report is for a 3.5mm locking screw.This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 45MM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7942783
• Report Number: 2939274-2018-54215
• Device Sequence Number: 856629
• Product Code: JDS
• UDI-Device Identifier: 10886982151933
• UDI-Public: (01)10886982151933
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K072095
• 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): 09/18/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 212.119
• Device Catalogue Number: 212.119
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/08/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention