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

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Type  Injury  

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 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).

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
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8130308
• MDR Text Key: 129299467
• Report Number: 2939274-2018-55256
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982085306
• UDI-Public: (01)10886982085306
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.005.418
• Device Catalogue Number: 04.005.418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR