MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INT HEX CAP SCREW 4.5MM X 60MM; NAIL, FIXATION, BONE

Model Number	71642160
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	05/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after placing a int hex cap screw 4.5mm x 60mm, the doctor made the decision to change it for a shorter one, since the initial screw was very long.The procedure was completed, without delay, using a s+n back-up device.Patient was not harmed.
Additional Manufacturer Narrative
G3, h2, h3, and h6: the device, used in treatment, was not returned for evaluation.A relationship, if any, between the device and the reported incidents could not be corroborated.The clinical/medical investigation concluded that, per e-mail communication, ¿the product or product packaging had no issue.The surgeon decided to use a different screw.¿ no patient injuries or adverse consequences were reported due to the change in screw.Since no patient injuries are being reported no further clinical/medical 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 causes could include but not limited to procedural variance, surgical technique or user error.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.G2: report source update.

• Brand Name: INT HEX CAP SCREW 4.5MM X 60MM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12022953
• Report Number: 1020279-2021-05254
• Device Sequence Number: 11663863
• Product Code: JDS
• UDI-Device Identifier: 03596010478948
• UDI-Public: 03596010478948
• Combination Product (Y/N): N
• PMA/510(K) Number: K981529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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: 71642160
• Device Catalogue Number: 71642160
• Device Lot Number: 16KT76827
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 08/18/2021
• 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: Hospitalization; Other; Required Intervention