MAUDE Adverse Event Report: SMITH & NEPHEW, INC. WASHER 8MM O.D. 4MM I.D; PLATE, FIXATION, BONE

Model Number	71120006
Medical Device Problem Codes	Expiration Date Error (2528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after surgery the circulator noticed that the implant sticker shows that the implant was expired.The implant still remains inside the patient.The patient outcome is unknown.
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, it was reported that the product was implanted in the patient was beyond the expiration date.Per e-mail communication the washer was incorporated with and antibiotic rod which was already planned to be remove six weeks following implantation.It was also noted that the patient is doing fine.Since no patient harm is being reported and no adverse consequence is anticipated as a result of this occurrence, no further clinical assessment is warranted at this time.A review of the complaint history did not reveal additional complaints for the listed batch.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 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.Possible probable cause could include but not limited to user error.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: WASHER 8MM O.D. 4MM I.D
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10215886
• Report Number: 1020279-2020-02848
• Device Sequence Number: 16785424
• Product Code: HRS
• UDI-Device Identifier: 03596010174338
• UDI-Public: 03596010174338
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K993106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2018
• Device Model Number: 71120006
• Device Catalogue Number: 71120006
• Device Lot Number: 08KM12540
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other