MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM X 20MM CTX SCR S-T; SCREW, FIXATION, BONE

Model Number	72403520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	11/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a patient with a fractured humerus had surgery 7 weeks ago.In the procedure, the physician used a 15 hole proximal humerus plate with locking screws in to the head and non-locking screws distally.The bone purchase was described as excellent.Recently, the patient experience sudden pain.X-ray images showed that the heads of the distal non-locking screws appeared to have been sheered off and one pulled out.The patient's condition is unknown.
Event or Problem Description
It was reported that a surgery on a patient with a fractured humerus 7 weeks ago happened.The physician used a 15 hole proximal humerus plate with locking screws in to the head and non-locking screws distally.The bone purchase was excellent.Recently the patient experience sudden pain.X-ray images show that the heads of the distal non-locking screws appear to have sheered right off, and one pulled out.In total 4 screw were broken.The physician used locking screws in the distal holes and added 3 more screws than initially implanted on the primary surgery.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that, this case reports that 7 weeks post-implantation, the heads of the distal non-locking screws appear to have sheared off, and one pulled out of a 15-hole proximal humerus plate; in total 4 screw were broken.Per email communication, there was non-adherence to post-op restrictions, etoh abuse, and multiple recent hip surgeries which could not be ruled out as contributing factors; therefore the surgeon reportedly does not consider this a device failure, "but a combination of patient factors." the requested surgical reports and x-rays have not been provided, therefore, the root cause of the event could not be thoroughly assessed.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but are not limited to traumatic injury, excessive pressure on the joint or patient condition.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: EVOS 3.5MM X 20MM CTX SCR S-T
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11060814
• Report Number: 1020279-2020-07730
• Device Sequence Number: 11024652
• Product Code: HWC
• UDI-Device Identifier: 00885556634356
• UDI-Public: 00885556634356
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K162078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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: 72403520
• Device Catalogue Number: 72403520
• Initial Date Received by Manufacturer: 11/27/2020
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EVOS 3.5MM CVD PROX HUM PL 15H L 213MM
• Outcome Attributed to Adverse Event: Required Intervention