MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 60MM FOR IM NAILS; SCREW, FIXATION, BONE

Model Number	04.005.550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Information reported on maude report: (original description).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.(b)(4).
Event or Problem Description
This report is against user facility medwatch number mw5087929, a copy is attached.The only information contained in this report is correction or additional information.It is unknown if there was a surgical delay.Patient status and surgical outcome were unknown.Concomitant device reported: femoral nail (part unknown, lot unknown, quantity 1), helical blade (part unknown, lot unknown, quantity 1).This report is for a locking screw.This is report 1 of 1 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 60MM 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: 8893954
• Report Number: 2939274-2019-59824
• Device Sequence Number: 18911644
• Product Code: HWC
• UDI-Device Identifier: 10886982086181
• UDI-Public: (01)10886982086181
• Combination Product (Y/N): N
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.005.550
• Device Catalogue Number: 04005550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/14/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention