MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CORTSCR Ø4.5 SELF-TAP L38 SST; SCREW, FIXATION, BONE

Model Number	214.838
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 510k: k974537 ktt.Device malfunctioned intra-operatively and was not implanted / explanted.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.Investigation summary: dhr review could not be conducted due the insufficient information¿s.Product was not returned and no lot number was provided.Based on the information available, 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.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 the patient had original surgery on (b)(6) 2018, for treatment of a proximal femur fracture.The patient was implanted with one (1) 130 degree/62mm standard barrel 3 hole 62mm and screws.Inter-operative, it was reported that a 4.5 cortical screw broke during implantation.The entire head of the screw broke off along with 2mm of the shaft.The screw shaft fragment was left in the patient bone.It was reported that the patient had hard bone on the spot and the resident used more force than necessary when the screw broke.All screw hole position on the plate was filled.Another screw was available in the operating room.This new screw was implanted just below the shaft in the plate.The broken implant has been retained by the hospital.No additional medical intervention was needed.Surgery was completed successfully with no time delay.The patient is reported in stable condition.Sales consultant has no more information to report on this event.Concomitant devices: 130 degree dhs® plate standard barrel 3 holes 62mm (item # 281.031, lot number unknown, quantity 1 each) unknown screwdriver (item # unknown, lot number unknown, quantity 1 each) unknown screw (item # unknown, lot number unknown, quantity unknown) this report is for one (1) device this report is 1 of 1 for: (b)(4).
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Event date corrected from (b)(6) 2018 - (b)(6) 2018.Device 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: CORTSCR Ø4.5 SELF-TAP L38 SST
• 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: 7404522
• Report Number: 2939274-2018-51529
• Device Sequence Number: 785905
• Product Code: HWC
• UDI-Device Identifier: 10886982154682
• UDI-Public: (01)10886982154682(10)LOTUNK
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2018

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: 214.838
• Device Catalogue Number: 214.838
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR