MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP TI 1.5MM X 10MM CTX SCR T4 S-T; PLATE, FIXATION, BONE

Model Number	74401510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/31/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery when inserting the screws, the heads sheared off mid-case leaving just the screw shaft in the bone.Bone was normal and no excessive force was used.The shafts were left in the bone as they were flush with the cortical wall and would cause more damage trying to remove.There was a delay between 0 and 30 min.A back-up device was not available, the procedure was completed with the device in question.
Event or Problem Description
It was reported that during surgery when inserting the screws, the heads sheared off mid-case leaving just the screw shaft in the bone.Bone was normal and no excessive force was used.The shafts were left in the bone as they were flush with the cortical wall.There was no further patient impart and the procedure was successfully completed with a slight delay of 30 minutes or less.
Additional Manufacturer Narrative
Results of investigation: the devices, used in treatment, were not returned for evaluation since the screws were not needed to be removed from the bone to successfully complete surgery.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.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 complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Our clinical/medical team noted: no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.It was reported that when inserting the 2 x 10mm 1.5mm vlp mini mod screws into ¿normal bone¿, ¿the heads just stripped easily without force and this resulted in a deficit of screws¿ and no backup device was available.No significant delay was reported.The shafts were left ¿in the bone as they were flush with the cortical wall and would cause more damage trying to remove¿.Although surgical details were not provided, the surgical technique 04918 v3 71081168 rev a 01/17 does indicate tapping the bone may be desired prior to insertion in dense cortical bone and the screw should always be finished by hand (not power), with final tightening using a two finger technique.Should clinical documentation become available, the medical investigation task may be re-evaluated.No further medical assessment is warranted at this time.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: VLP TI 1.5MM X 10MM CTX SCR T4 S-T
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9621185
• Report Number: 1020279-2020-00366
• Device Sequence Number: 585294
• Product Code: HRS
• UDI-Device Identifier: 00885556489345
• UDI-Public: 00885556489345
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K143050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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 Model Number: 74401510
• Device Catalogue Number: 74401510
• Device Lot Number: 19CM13714
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 11/04/2020
• 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