MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM L-P TIB LK PL13H R 255MM; PLATE, FIXATION, BONE

Catalog Number	71800313
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to an implant fracture.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, the two x-rays provided confirm the broken plate and a tibial non-union.However, without the requested clinical information or the explant the root cause of the implant fracture cannot be determined.The further impact to the patient beyond the revision cannot be concluded.Should any additional clinical information be provided this complaint would be re-assessed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.

• Brand Name: 4.5MM L-P TIB LK PL13H R 255MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8851045
• Report Number: 1020279-2019-02888
• Device Sequence Number: 319249
• Product Code: HRS
• UDI-Device Identifier: 03596010520241
• UDI-Public: 03596010520241
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: 08/31/2024
• Device Catalogue Number: 71800313
• Device Lot Number: 14JM01366
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 11/05/2019
• 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: Hospitalization
• Patient Age: 56 YR
• Patient Weight: 65