MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 85/80; NAIL, FIXATION, BONE

Catalog Number	71675501
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient who had intertan operation on (b)(6) 2017 at this hospital had pain and took x-ray at other hospital, then it was noted that the nail was broken.Revision surgery (bhr) wil be performed.No more information shown.
Additional Manufacturer Narrative
Correct part number and udi added.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A lab analysis concluded that the intertan nail fractured by the initiation and subsequent propagation of fatigue cracking.The fracture likely initiated on the lateral side of the nail through the lag screw hole.The fatigue cracking eventually propagated to an extent that the remaining cross-sectional area of the nail could not bear the imposed patient loading, which led to an overload fracture of the nail.Fatigue cracking is caused by the nail 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 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, and/or poor bone quality.No material deviations were found during this investigation.A clinical evaluation states this case reports a ¿revision surgery (bhr) will be performed¿ but this has already been revised to a femoral stem with a tandem bipolar head and not a bhr implant due to a broken intertan nail.Four x-ray where provided which demonstrate the intertrochanteric fracture and repair with cerclage wires and intramedullary nail and a femoral fracture plate and a broken nail with a non-union of the intertrochanteric fracture, repaired with a femoral stem and bipolar head and cerclage wiring one x-ray confirms the presence of the broken nail.There are no additional medical documents available for review.Additionally, there is no report of the patient¿s current condition following the revision.However, it is likely the patient will experience pain and have possibly have post op rehab.Should additional information be provided, the clinical/medical investigation can be re-evaluated at that time.

• Brand Name: LAG/COMP SCREW KIT 85/80
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8329455
• Report Number: 1020279-2019-00528
• Device Sequence Number: 14024406
• Product Code: JDS
• UDI-Device Identifier: 03596010563293
• UDI-Public: 03596010563293
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/22/2019

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: 71675501
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 01/22/2019; 01/22/2019; 01/22/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 04/04/2019; 10/22/2019; 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71677085,71645027,71340011
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention