MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP TI 1.5MM X 13MM CTX SCR T4 S-T; PLATE, FIXATION, BONE

Catalog Number	74401513
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a plate implantation a screw broke.The head was recovered but the shaft was left inside the patient's phalanx.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation the associated complaint device was not returned.A visual inspection of the attached photo shows the broken head of the screw.The rest of the screw remains implanted in the patient.A clinical analysis confirms that a peri-loc screw broke during insertion.The screw head broke off and was removed and discarded, and the remained of the screw remains in the bone.Further, the procedure was completed using more screws to keep the plate in place and ensure its functionality.There are no radiographs or medical documentation provided for review.The retained screw is an implantable, biocompatible device, therefore is no anticipated adverse effect on the patient, and no patient injury is being reported.No further clinical assessment is warranted.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: VLP TI 1.5MM X 13MM 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: 7054540
• Report Number: 1020279-2017-01091
• Device Sequence Number: 1211534
• Product Code: HRS
• UDI-Device Identifier: 00885556489499
• UDI-Public: 00885556489499
• Combination Product (Y/N): N
• PMA/510(K) Number: K143050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2018

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 Catalogue Number: 74401513
• Initial Date Received by Manufacturer: 11/18/2017
• Supplement Date Received by Manufacturer: 11/18/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 04/02/2018
• 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: Disability
• Patient Age: 47 YR
• Patient Weight: 60