MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM X 75MM LCK SCR S-T; PLATE, FIXATION, BONE

Model Number	72413575
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection, (3) evos 3.5mm x 75mm lck scr s-t were found to be incorrectly packaged, because the screws on the package were 70cm screws and not 75cm screws.There was no patient involved.
Additional Manufacturer Narrative
H6, h7 and h9: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures for the listed batch; this failure mode will be monitored for future complaints for any necessary corrective actions.However, internal investigation concluded that this event was previously identified and investigated.Based on the quality investigation, the root cause of the reported event was the failure to ensure shop order paperwork matches actual product during the manufacturing process.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.As a result of the investigation, several process improvements were implemented related to training, process monitoring and in process inspection.In addition, containment and remedial actions were performed for the impacted finished product.Should additional information be received, the complaint will be reopened.We will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Remedial action is associated with internal reference # r-2021-09.

• Brand Name: EVOS 3.5MM X 75MM LCK SCR S-T
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12450132
• Report Number: 1020279-2021-06761
• Device Sequence Number: 11574523
• Product Code: HRS
• UDI-Device Identifier: 00885556637159
• UDI-Public: 00885556637159
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2021

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: 72413575
• Device Catalogue Number: 72413575
• Device Lot Number: 21FM24289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 12/06/2021; 12/06/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 12/06/2021; 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: SEE H10
• Patient Sequence Number: 1
• Patient Sex: Unknown