MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 4.5MM HEADLESS COMPRESSION SCREW/LONG THREAD/50MM; SCREW, FIXATION, BONE

Model Number	02.226.750
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.This report is against user facility medwatch number (b)(4), a copy is attached.The only information contained in this report is correction or additional information.Part of device remains in the patient; device not considered implanted/explanted during the initial procedure on (b)(6) 2017.Device is not expected to return for 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.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
This report is against user facility medwatch number (b)(4)., a copy is attached.The only information contained in this report is correction or additional information.It was reported that a patient had open reduction internal fixation (orif) of the left 5th metatarsal on (b)(6) 2017.The first 4.5 mm screw that was implanted broke into two pieces inside the metatarsal.The physician retrieved half of the screw without any difficulty and the other half was retained inside the metatarsal.An additional 6.5 mm screw was placed through the fracture site to gain reduction.The patient was discharged home with follow up planned in 2-3 weeks.The procedure was successfully completed with no reported surgical delay.No additional medical intervention was required to complete the procedure.No unanticipated x-rays were taken.Concomitant parts : unknown screwdriver (unknown part and lot number, unknown quantity).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Corrected data: device is a single use device but was not reprocessed or reused.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.5MM HEADLESS COMPRESSION SCREW/LONG THREAD/50MM
• 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: 7151489
• Report Number: 2939274-2017-50462
• Device Sequence Number: 10976418
• Product Code: HWC
• UDI-Device Identifier: 10886982060303
• UDI-Public: (01)10886982060303(10)UNKNOWNLOTNUMBER
• Combination Product (Y/N): N
• PMA/510(K) Number: K080943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 02.226.750
• Device Catalogue Number: 02226750
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 01/25/2018; 04/13/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 01/25/2018; 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR
• Patient Weight: 86