MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 40MM; SCREW, FIXATION, BONE

Model Number	204.840
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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) 2019, during a tibia plateau, the cortex screw was broken on a lateral proximal tibial plate of the patient left proximal tibia.The other part of the cortex screw is still in the patient.There was a surgical delay.Procedure was successfully completed.Patient outcome was unknown.Concomitant device reported: unknown proximal tibial plate (part #: unknown, lot #: unknown, quantity # 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
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.D2: additional device procode: jds.H3, h6: product investigation was completed.It was visually observed that the screw has sheared off just below the 3rd and 4th threads of the shaft.The broken shaft/distal tip was not returned.The material surface at the fracture site appears homogeneous with no voids or abnormalities when viewed under 10x magnification at customer quality.Complaint condition can not be replicated because plate and distal part of screw were not received.The received condition does agree with the complaint description for broken and is confirmed.It is unconfirmed for functional embedded device.The cause of the issue could not be determined to be use error, misuse/abuse, noncompliance, postoperative trauma.Dimensional analysis was performed and met specifications.Relevant drawings were reviewed.No design or manufacturing defect or deficiency was observed during the investigation.While no definitive root cause could be determined it is possible that the device excessive force during insertion or removal resulting in the breakage.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 further reported that most distal screw in lateral plate.The surgeon said he drilled perpendicular to the plate but screw skived distally and snapped off.There was surgical delay for unknown length of time.

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 40MM
• 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: 8383703
• Report Number: 2939274-2019-56766
• Device Sequence Number: 420675
• Product Code: HWC
• UDI-Device Identifier: 10886982146380
• UDI-Public: (01)10886982146380
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• 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,Followup
• Report Date (Section B): 02/07/2019

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: 204.840
• Device Catalogue Number: 204.840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 03/29/2019
• Patient Sequence Number: 1
• Patient Age: 45 YR