MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PERI-LOC 4.5MM TI L-D FEM PL 8H R 193MM; PLATE, FIXATION, BONE

Model Number	71860106
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
(b)(4).It was reported that, there was a revision surgery due to peri-loc 4.5mm titanium l-d fem pl 6h r 155mm breakage, this device was explanted.The procedure was completed with a competitor device (stryker plate).No surgical delay was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that, there was a revision surgery due to peri-loc 4.5mm titanium l-d fem pl 8h r 193mm breakage, this device was explanted.The procedure was completed with a competitor device (stryker plate).No surgical delay was reported.
Additional Manufacturer Narrative
The associated device was returned and evaluated.Based on this investigation it was concluded that the periloc plate fractured by the initiation and subsequent propagation of fatigue cracking.The fatigue cracking eventually propagated to an extent that the remaining cross section could not bear the imposed patient loading, which led to an overload fracture.Fatigue cracking is caused by the plate bearing cyclic stresses in excess of the material endurance limit for an extended period.These excessive cyclic stresses may be caused by any number of conditions, including but not limited to excessive patient activity levels prior to full bone union applications of loads in excess of the material¿s strength, or poor bone quality.No material or manufacturing deviations were observed during this investigation.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The clinical/medical evaluation concluded that the photo is the device was provided and confirms the failure.However, without the requested relevant clinical information, the implantation/revision report, the pre/post implantation x-rays, bone quality or fall history the root cause of the reported breakage cannot be determined.Per the report, all the devices were removed, and the procedure was completed with a competitor device (stryker plate).Since there were no surgical delay or other complications reported, no further clinical/medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: PERI-LOC 4.5MM TI L-D FEM PL 8H R 193MM
• Common Device Name: 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 11113376
• Report Number: 1020279-2021-00062
• Device Sequence Number: 17068325
• Product Code: HRS
• UDI-Device Identifier: 03596010640161
• UDI-Public: 03596010640161
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71860106
• Device Catalogue Number: 71860108
• Device Lot Number: 19AT15119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 01/04/2021; 03/22/2022
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 01/27/2021; 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71867070, 71867068, 71867062, 71867058,, 71867034,
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown