MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM LCK COMP PL 12H 229MM; PLATE, FIXATION, BONE

Catalog Number	14KT47314
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery for a broken straight plate, replaced by a 10 hole chs plate.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.The lab analysis concluded, the purpose of this investigation was to examine the returned device.No destructive analysis was conducted.Due to the size of the plate, the fracture surface was unable to be evaluated using the sem.From the analyses conducted during this investigation, the exact cause of the reported failure was not able to be determined.The clinical/medical team concluded, no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.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 part revealed no prior complaints for the listed batch.If new information is received in the future, this complaint can be re-opened.

• Brand Name: 4.5MM LCK COMP PL 12H 229MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8181464
• Report Number: 1020279-2018-02839
• Device Sequence Number: 2306839
• Product Code: HRS
• UDI-Device Identifier: 03596010523297
• UDI-Public: 03596010523297
• Combination Product (Y/N): N
• PMA/510(K) Number: K033669
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2019

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: 10/20/2019
• Device Catalogue Number: 14KT47314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Initial Date Received by Manufacturer: 11/22/2018
• Supplement Date Received by Manufacturer: 11/22/2018; 11/22/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/07/2019; 05/19/2019
• 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; Required Intervention