MAUDE Adverse Event Report: LAG/COMP SCREW KIT 100/95; NAIL, FIXATION, BONE

Model Number	71677100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after tha surgery had been performed on (b)(6) 2020, the patient experienced pain.This adverse event was solved by revision surgery on (b)(6) 2021, it was found that the compression screw was broken.After cutting the femoral head, the lag and compression screws were removed.Current health status of patient 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, smith and nephew has not received the device/or any adequate relevant clinical information to fully evaluate the complaint.Based on the information provided, during the revision surgery after cutting the femoral head, the lag and compression screws, the surgeon removed them from femoral head side.Subsequently, it was ¿found the compression screw was broken.¿ according to the report, a 30-minute procedural delay was reported.The impact to the patient beyond that which has already been reported cannot be determined.Should any additional medical information be provided, this complaint would be re-assessed.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.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.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.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.

• Brand Name: LAG/COMP SCREW KIT 100/95
• Common Device Name: NAIL, FIXATION, BONE
• MDR Report Key: 12475683
• Report Number: 1020279-2021-06886
• Device Sequence Number: 14290301
• Product Code: JDS
• UDI-Device Identifier: 03596010563323
• UDI-Public: 03596010563323
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

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: 71677100
• Device Catalogue Number: 71677100
• Device Lot Number: 19KT30109
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 11/01/2021
• Date Device Manufactured: 10/30/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR