MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INT HEX RC SCR BL 6.4X115; NAIL, FIXATION, BONE

Model Number	71642315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a trauma surgery, the int hex rc scr bl 6.4x115 was expired and used in the procedure.The procedure was completed with the same device and it was unknown if there was any surgical delay.Patient was not harmed.
Event or Problem Description
It was reported that, during a trauma surgery, the int hex rc scr bl 6.4x115 was expired and used in the procedure.The procedure was successfully completed without delay using the same device.Patient was not harmed.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the pictures were reviewed and the failure mode was confirmed.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 complaint history did not reveal additional complaints for the listed batch.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: INT HEX RC SCR BL 6.4X115
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11922310
• Report Number: 1020279-2021-04958
• Device Sequence Number: 14269945
• Product Code: JDS
• UDI-Device Identifier: 03596010516664
• UDI-Public: 03596010516664
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K981529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2021

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 Expiration Date: 07/12/2019
• Device Model Number: 71642315
• Device Catalogue Number: 71642315
• Device Lot Number: 09GM06902
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 06/03/2021; 07/07/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/11/2021; 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1