MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 4.7MM X 46MM OST SCR PT; SCREW, FIXATION, BONE

Catalog Number	72434746
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that patient had a trimalleolar fracture fixation, fixed with evos.Problem occurred with the fixation of the medial malleolus.Reduced with a k-wire, inserted 2.5 drill as per operative technique for a 4.7 cancellous screw, the screw would not engage or advance into the drilled hole.Delay from (30 minutes - 1 hour) reported.Backup device available.No injury or impact to patient reported.Patient is 40 years old, no pre-exisiting co-morbidities and has good bone quality.
Additional Manufacturer Narrative
Results of investigation: the associated evos 4.7mm osteopenia screw was not returned for evaluation.Therefore a product analysis could not be performed.The lot number has not been provided as the device was discarded at the hospital.As device details were not made available, device history record review cannot be completed.Complaint history review could not be performed with any accuracy due to lack of batch information.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: EVOS 4.7MM X 46MM OST SCR PT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8742940
• Report Number: 1020279-2019-02501
• Device Sequence Number: 11182622
• Product Code: HWC
• UDI-Device Identifier: 00885556637753
• UDI-Public: 00885556637753
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K162078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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 Catalogue Number: 72434746
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR