MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 11.5MM X 40CM; NAIL, FIXATION, BONE

Model Number	71655240
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, dr.(b)(6) were tried to realign the nail when inserting it into the patient.During that process the proximal end of the nail was sheered off.No more information available.
Additional Manufacturer Narrative
It was reported that during the procedure, the surgeon tried to realign the nail when inserting it into the patient.During that process the proximal end of the nail was sheered off.The affected trigen meta-nail, used in treatment, was returned and evaluated.A lab analysis during this investigation noted the device fractured by the initiation and subsequent propagation of shear forces.The fracture likely initiated on the lateral side of the nail through the proximal hole.The shear forces quickly propagated in q quasi-stactic manner to an extent that the cross-sectional area of the nail could not bear the imposed loading.Our investigation including a review of the manufacturing records for the listed batch 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.Possible causes could include but not limited to assembly issue, unclear user instructions or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: META-NAIL TIBIAL 11.5MM X 40CM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9227133
• Report Number: 1020279-2019-03718
• Device Sequence Number: 13936861
• Product Code: JDS
• UDI-Device Identifier: 03596010585714
• UDI-Public: 03596010585714
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71655240
• Device Catalogue Number: 71655240
• Device Lot Number: 18MM13105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 02/09/2020
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1