MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 34MM; SCREW,FIXATION,BONE

Model Number	204.834
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patent identifier: (b)(4).Additional product code hrs jds.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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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) 2020, during a tibial plateau open reduction internal fixation (orif) while inserting a 3.5 cortex screw on power, the head of the screwdriver snapped off into the head of the screw.A medial incision was made, and the screw was backed out and removed and replaced.All fragments removed from the patient.Action taken when the event occurred medial incision to back the screw out.There was a surgical delay of 30 (thirty) minutes.The procedure was successfully completed.There was no patient consequence.This complaint involves 2 devices.This report is for (1) 3.5mm cortex screw self-tapping 34mm.This report is 1 of 2 for (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 34MM
• 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: 11073604
• Report Number: 2939274-2020-05706
• Device Sequence Number: 2684105
• Product Code: HWC
• UDI-Device Identifier: 10886982146359
• UDI-Public: (01)10886982146359
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 204.834
• Device Catalogue Number: 204.834
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/25/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 83