MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PERI-LOC 4.5MM TI L-D FEM PL 13H L 286MM; PLATE, FIXATION, BONE

Model Number 71860013

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 06/21/2021

Event Type  Injury  

Event Description

It was reported that, after an internal fixation surgery had been performed on (b)(6) 2021, on (b)(6) 2021 the peri-loc 4.5mm ti l-d fem pl 13h l 286mm broke inside the patient while doing rehabilitation at home.A revision surgery has been scheduled for (b)(6) 2021.Current health status of patient is unknown.

• Brand Name: PERI-LOC 4.5MM TI L-D FEM PL 13H L 286MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12119167
• MDR Text Key: 260034932
• Report Number: 1020279-2021-05712
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 03596010640147
• UDI-Public: 03596010640147
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71860013
• Device Catalogue Number: 71860013
• Device Lot Number: 19CT19044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention