MAUDE Adverse Event Report: SMITH & NEPHEW, INC. P-L VLP 3.5MM PM-P TIBIA LK PL 7H R 98MM; PLATE, FIXATION, BONE

Catalog Number	72820207
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a surgical intervention was performed due to a broken plate.The plate was removed.
Additional Manufacturer Narrative
The associated peri-loc vlp proximal tibial plate was not returned for evaluation.No clinical relevant information was provided, therefore, a thorough medical investigation could not be performed.However, should a fragment of the "blocked screw" be retained in the bone, it is an implantable alloy, although it remains unknown if micro-motion is possible.The patient impact beyond the revision procedure itself cannot be determined based on information provided.No further medical assessment is warranted at this time.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive. 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.Should additional information be received, the complaint will be reopened.

• Brand Name: P-L VLP 3.5MM PM-P TIBIA LK PL 7H R 98MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7648779
• Report Number: 1020279-2018-01228
• Device Sequence Number: 1512544
• Product Code: HRS
• UDI-Device Identifier: 00885556067062
• UDI-Public: 00885556067062
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K062216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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: 72820207
• Device Lot Number: 16FM02809
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 10/06/2018
• 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: Other; Required Intervention
• Patient Age: 31 YR