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

Catalog Number	71655236
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgical procedure, it was noticed that the proximal part of the 11.5mmx36 cm tibia nail was fractured.
Event or Problem Description
It was reported that during the surgical procedure, it was noticed that the proximal part of the 11.5mmx36 cm tibia nail was fractured.The surgery was stopped and another surgery will be scheduled to implant a non-fracture nail.No pieces fell or were left into the patient.
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.We consider this investigation closed.

• 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: 8346580
• Report Number: 1020279-2019-00606
• Device Sequence Number: 16721267
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71655236
• Device Lot Number: 17JM06584
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 01/24/2019; 01/24/2019
• Initial Report FDA Received Date: 02/17/2019
• Supplement Report FDA Received Date: 03/05/2019; 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 106