MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CANNULATED SCREW LONG THREAD/50MM; SCREW,FIXATION,BONE

Model Number	207.750
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not removed.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.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, during an unknown procedure, the cannulated screw long thread broke while implanting.There were fragments generated from the broken device but they could not be retrieved.Xrays were performed intra-operatively.The device remains implanted.The procedure was successfully completed with a 15-minute surgical delay.Patient outcome is unknown.Concomitant device reported: 1.6mm threaded guide wire (part# 292.72, lot# unknown, quantity# 4).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: additional patient identifier: (b)(6).No product was returned; the investigation was performed based on the received medical images.Upon review of the medical images, it can be confirmed that the screw broke into two pieces at the transition from the smooth shaft to the distal threads.The cause for the damage could not be determined.A review of the device history records could not be performed due to the unknown lot number.Based on the information available, it has been determined that no corrective and 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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional 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.

• Brand Name: 4.0MM CANNULATED 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: 7914039
• Report Number: 2939274-2018-53963
• Device Sequence Number: 16379028
• Product Code: HWC
• UDI-Device Identifier: 10886982148551
• UDI-Public: (01)10886982148551
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K963192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 207.750
• Device Catalogue Number: 207.750
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 10/08/2018; 10/17/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 10/16/2018; 10/17/2018
• Patient Sequence Number: 1
• Patient Age: 14 YR