MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COM SCREW KIT 115/110; NAIL, FIXATION, BONE

Model Number	71677115
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, we measured for a 115/110 screw kit.After starting to advance the lag screw in we noticed the lag screw was way longer than what the doctor had measured.After discovering the screw was too long, the doctor requested a shorter screw kit.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device shows signs of damage from attempted use.The medical investigation concluded that responses to the information requests have not been received as of the date of this assessment.Based on the limited information provided, the root cause of the reported event could not be definitively concluded.The patient impact beyond the reported use of an additional device and possible modified surgical procedure could not be determined.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.The dimensional inspection found the lag screw was within specification for length.A review of 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could a measurement error or procedural variance.Based on this investigation, the need for corrective action is not indicated.Should 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: LAG/COM SCREW KIT 115/110
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10264817
• Report Number: 1020279-2020-03144
• Device Sequence Number: 16860308
• Product Code: JDS
• UDI-Device Identifier: 03596010560858
• UDI-Public: 03596010560858
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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 Expiration Date: 09/03/2025
• Device Model Number: 71677115
• Device Catalogue Number: 71677115
• Device Lot Number: 15JT58578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 07/23/2021
• 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: Required Intervention