MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM L-D FEM LK PL13H L 286MM; PLATE, FIXATION, BONE

Model Number	71800013
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a plate breakage.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to a plate breakage.The affected peri-loc locking plate along with the screws, used in treatment, was returned.A lab analysis was conducted and noted that the plate fractured by the initiation and subsequent propagation of fatigue cracking.The fatigue cracking eventually propagated to an extent that the remaining cross-sectional area of the locking plate could not bear the imposed patient loading, which lead to an overload fracture.Fatigue cracking is caused by the plate bearing cyclic (i.E.Repeated) stresses in excess of the material endurance limit for an extended period of time.These excessive cyclic stresses may be caused by any number of conditions, including but not limited to (1) excessive patient activity levels prior to full bone union, (2) applications of loads in excess of the material¿s strength, and/or (3) poor bone quality.A review of the manufacturing records for the listed part did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A medical analysis noted x-rays provided shows that there is a non-union of the distal femoral fracture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: 4.5MM L-D FEM LK PL13H L 286MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9135147
• Report Number: 1020279-2019-03500
• Device Sequence Number: 2717158
• Product Code: HRS
• UDI-Device Identifier: 03596010520036
• UDI-Public: 03596010520036
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K092015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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 Model Number: 71800013
• Device Catalogue Number: 71800013
• Device Lot Number: 18EM18162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 09/02/2019
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCREW, # 71806036, LOT # 19BM15676.; SCREW, # 71806052, LOT # 18CM05139.; SCREW, # 71807020, LOT # 15EUQ0008.; SCREW, # 71807038, LOT # 15HUQ0013.; SCREW, # 71807040 LOT # 18CM17670.; SCREW, # 71807046 LOT # 15CUQ0033.; SCREW, # 71807076 LOT # 18FM08822.; SCREW, # 71807090, LOT # 13CM09501.; SCREW, 71807036, LOT # 17KB01289.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 90