MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM LCK TUBULAR PL 6H 82MM; PLATE, FIXATION, BONE

Model Number	71829006
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to failure of plate after 4 weeks since implanted.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.Based on the lab analysis, it was concluded that the locking tubular 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 of time.These excessive cyclic stresses may be caused by any applications of loads in excess of the material¿s strength, or poor bone quality.No material or manufacturing deviations were observed during this investigation.The medical investigation concluded that no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.A review of complaint history did not reveal additional complaints for the listed batch.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 have no 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 documents revealed this failure mode was previously identified.Some potential probable causes of this event could include material overloading or overstressing.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 for future complaints and investigate as necessary.

• Brand Name: 3.5MM LCK TUBULAR PL 6H 82MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9131856
• Report Number: 1020279-2019-03495
• Device Sequence Number: 11515055
• Product Code: HRS
• UDI-Device Identifier: 03596010525567
• UDI-Public: 03596010525567
• Combination Product (Y/N): N
• PMA/510(K) Number: K033669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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: 71829006
• Device Catalogue Number: 71829006
• Device Lot Number: 14CT40597
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 02/26/2020
• 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: Required Intervention