MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 85MM FOR IM NAILS; SCREW, FIXATION, BONE

Model Number	04.005.575
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s mrn reported as (b)(6).This information is unknown.It is unknown when screws were determined to be incorrect length.Lot number is unknown.Date of implantation is unknown.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.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.(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 (b)(6) 2018, the patient underwent an explantation procedure.Two (2) titanium locking screws with stardrive for intramedullary nails (im) were removed from an unknown retrograde femoral nail.The screws were too long and were replaced with two screws of the appropriate length without incident.The procedure was successfully completed with no surgical delay.The patient was stable following surgery.Concomitant devices reported: retrograde femoral nail (part: unknown, lot: unknown, quantity: 1).This report is for a 5.0mm ti locking screw w/t25 stardrive 85mm for im nails.This is report 1 of 2 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 85MM FOR IM NAILS
• 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: 7685370
• Report Number: 2939274-2018-52864
• Device Sequence Number: 16507115
• Product Code: HWC
• UDI-Device Identifier: 10886982086402
• UDI-Public: (01)10886982086402
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/18/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.005.575
• Device Catalogue Number: 04.005.575
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 07/13/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR