MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 11.5MM X 36CM; NAIL, FIXATION, BONE

Catalog Number	71655236
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A second surgery was performed to implant a non-fractured meta-nail tibial.The procedure was completed successfully.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the case should be handled in one complaint since the malfunction is the cause that led to the medical intervention as an ongoing issue (reported in mdr 1020279-2019-00606), therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
Additional Manufacturer Narrative
The associated complaint device was returned for evaluation.Our lab analysis confirms the returned meta-tan nail was examined visually.A fracture was observed at the proximal end of the nail as reported.Disruption of the anodization at the center was also observed.Burnishing of the nail is caused by motion or rotation in vivo or during insertion/removal.No materials or manufacturing deviations were found in this investigation.A review of complaint history on the listed part revealed no prior complaint for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities 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.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: META-NAIL TIBIAL 11.5MM X 36CM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8421187
• Report Number: 1020279-2019-01071
• Device Sequence Number: 2227490
• Product Code: JDS
• UDI-Device Identifier: 03596010585677
• UDI-Public: 03596010585677
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K061019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2019

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 Catalogue Number: 71655236
• Device Lot Number: 17JM06584
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 06/12/2019; 06/12/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 06/12/2019; 06/12/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 27 YR
• Patient Weight: 106