MAUDE Adverse Event Report: SMITH & NEPHEW, INC. P-L VLP 3.5MM 1/3 LK TUB PL 8H 98MM; PLATE, FIXATION, BONE

Catalog Number	72803008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2017, the patient underwent debridement and suture of the left lower leg, internal fixation of the humerus and plate fixation, and external fixation of the humerus surgery.He was discharged from the hospital with good recovery.After a year of reexamination, the plate was found to be broken and the fracture was not cured.

• Brand Name: P-L VLP 3.5MM 1/3 LK TUB PL 8H 98MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8421133
• Report Number: 1020279-2019-01070
• Device Sequence Number: 2051232
• Product Code: HRS
• UDI-Device Identifier: 03596010612434
• UDI-Public: 03596010612434
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

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 Catalogue Number: 72803008
• Device Lot Number: 16JM12504
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/14/2019
• 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
• Patient Age: 57 YR