MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM L-P TIB LK PL16H L 309MM; PLATE, FIXATION, BONE

Catalog Number	71800216
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due implant fractured.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A clinical analysis indicated that a revision was performed due to a broken peri-loc plate.There have been three attempts to obtain information, however no relevant supporting clinical information has been provided, and there is no report of the patient's current condition.Therefore, based on insufficient information, a clinical assessment cannot be performed at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed part.Without the actual product involved and/or device information, our investigation cannot proceed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.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: 4.5MM L-P TIB LK PL16H L 309MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7246036
• Report Number: 1020279-2018-00128
• Device Sequence Number: 13689276
• Product Code: HRS
• UDI-Device Identifier: 03596010520173
• UDI-Public: 03596010520173
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K092015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2020
• Device Catalogue Number: 71800216
• Device Lot Number: 10FM00761
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 06/02/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 25 YR