MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM FOR IM NAILS; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.005.418
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc synthes sales representative.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.The investigation could not be completed; no conclusion could be drawn.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.
Event or Problem Description
It was reported on (b)(6) 2018, the patient underwent a removal/revision of damaged titanium locking screws in the tibia nail on an unknown date.It was further reported, the titanium locking screw may have migrated and was removed and replaced with a longer screw.The unknown locking screw was broken and a piece was retained, another screw was placed.It is unknown if there was surgical delay.Patient outcome is unknown.Procedure was successfully completed.Concomitant device reported: unknown tibial nail (part# unknown, lot# unknown, quantity# 1).This complaint involves two (2) devices.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Reporter is a synthes employee.Additional information provided.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.

• Brand Name: 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM FOR IM NAILS
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8130308
• Report Number: 2939274-2018-55256
• Device Sequence Number: 19204244
• Product Code: HSB
• UDI-Device Identifier: 10886982085306
• UDI-Public: (01)10886982085306
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K103002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2018

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: 04.005.418
• Device Catalogue Number: 04.005.418
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 12/31/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 12/31/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR