MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/40MM; PLATE,FIXATION,BONE

Model Number	206.040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient ref.# (b)(6).Additional product code: hwc.Occupation: synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.Without a lot number the device history records review could not be completed.Product was not returned.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 during an open reduction internal fixation (orif) of the proximal humerus on (b)(6) 2019, the 4.0 cancellous screw snapped halfway into the intramedullary.The procedure was completed by retrieving the broken portion with narrow rongeurs, inside the canal, and then proceeding as planned, with plates and screws.The surgeon then elected to use a cortical screw, in place of the cancellous.The screw was being run threw a plate.The issue happened while the surgeon was implanting the reported screw.The procedure was successfully completed with 5 minutes surgical delay.The screw fragment was easily retrieved.There was no patient consequence reported.Concomitant device reported: unknown plate (part# unknown, lot# unknown, quantity 1).This is report 1 for 1 (b)(4).

• Brand Name: 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/40MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9186352
• Report Number: 2939274-2019-61512
• Device Sequence Number: 2323086
• Product Code: HRS
• UDI-Device Identifier: 10886982147349
• UDI-Public: (01)10886982147349
• Combination Product (Y/N): N
• Initial Reporter State: NC
• PMA/510(K) Number: K083213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2019

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: 206.040
• Device Catalogue Number: 206.04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/14/2019
• Patient Sequence Number: 1
• Patient Age: 24 YR