MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.7MM X 75MM LCK SCR T8 S-T; PLATE, FIXATION, BONE

Model Number	72412775
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, an evos 2.7mm x 75mm locking screw s-t was bent.The sales representative noticed it just after he took the device out of the packaging.No patient involvement or other complications were reported.
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.The visual inspection of the returned evos 2.7mm x 75mm lck scr t8 s-t appears to be bent in the middle.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.Some potential probable causes for this event could include damaged product, implant corrosion or wear.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship between the device and the reported incident was corroborated.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: EVOS 2.7MM X 75MM LCK SCR T8 S-T
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11431051
• Report Number: 1020279-2021-01841
• Device Sequence Number: 3618524
• Product Code: HRS
• UDI-Device Identifier: 00885556436547
• UDI-Public: 00885556436547
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/26/2021

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: 72412775
• Device Catalogue Number: 72412775
• Device Lot Number: 19LB01754
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1