MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP TI 1.5MM X 11MM LCK SCR T4 S-T; PLATE, FIXATION, BONE

Catalog Number	74411511
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported two screws broke on the mini mod set whilst being screwed into the bone.Both screws broke just under the locking mechanism and were left in the patient.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical analysis indicates that insufficient clinically relevant documentation was provided to perform a thorough medical assessment.The root cause of neither the locking screw breakage nor the patient impact beyond the retained screw shafts can be concluded.The surgical technique does indicate that only hand tightening with a two finger technique should always be used along with caution during final tightening.Should additional information become available, the clinical/medical assessment may be re-evaluated.A review of complaint history on the listed part revealed no prior complaints for the listed part number.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 11MM LCK 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: 7112708
• Report Number: 1020279-2017-01246
• Device Sequence Number: 1469347
• Product Code: HRS
• UDI-Device Identifier: 00885556490341
• UDI-Public: 00885556490341
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K143050
• 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): 04/03/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 74411511
• Initial Date Received by Manufacturer: 12/03/2017
• Supplement Date Received by Manufacturer: 12/03/2017
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74411510/UNKNOWN LOT
• Outcome Attributed to Adverse Event: Other