MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM LCK COMP PL 10H 193MM; PLATE, FIXATION, BONE

Catalog Number	71809310
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a plate implantation, when the patient was exercising at home, he suddenly had a tear in his right thigh with pain and limited mobility.The patient was re-admitted to the hospital and revision surgery was performed.
Additional Manufacturer Narrative
The associated complaint device was not returned.Per the photo provided, the implant did fracture into two pieces.A clinical evaluation was conducted and no clinically relevant documentation was provided, therefore a thorough medical investigation could not be performed.Should relevant documentation become available, the medical assessment task may be re-evaluated.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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: 4.5MM LCK COMP PL 10H 193MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7962899
• Report Number: 1020279-2018-02126
• Device Sequence Number: 201332
• Product Code: HRS
• UDI-Device Identifier: 03596010523280
• UDI-Public: 03596010523280
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 12/18/2018

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: 01/10/2018
• Device Catalogue Number: 71809310
• Device Lot Number: 13AT26957
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 12/18/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 32 YR