MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 32MM; SCREW,FIXATION,BONE

Model Number	214.832
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.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.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, the patient underwent a revision of proximal femur.On the final tightening a 4.5mm cortex screw head broke off.The screw head was removed but the screw shaft was retained.A screwdriver was used to tap the screw shaft through the near cortex out of the path for a future screw.Once the shaft was cleared, a new screw was placed into the same screw hole.There was a surgical delay of five (5) minutes.The procedure was completed successfully.Patient status is stable.Concomitant device: unknown screwdriver (part # unknown, lot # unknown, quantity 1) this report is for one (1) 4.5mm cortex screw self-tapping 32mm.This is report 1 of 1 for (b)(4).This complaint captures the intra-operative event while (b)(4) captures the post-operative event.

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 32MM
• 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: 8522888
• Report Number: 2939274-2019-57522
• Device Sequence Number: 2675723
• Product Code: HWC
• UDI-Device Identifier: 10886982154651
• UDI-Public: (01)10886982154651
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K974537
• 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): 03/25/2019

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: 214.832
• Device Catalogue Number: 214.832
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR